Sample records for fda staff class
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-28
... method comparison section and the sample selection inclusion and exclusion criteria section. The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-09
... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0465] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... guidance document will serve as the special control for rTMS systems. Section 513(f)(2) of the Federal Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-23
... test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls... devices into class II (special controls) because special controls, in addition to general controls, will...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
... and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov/MedicalDevices... ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' from CDRH you may...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-23
...: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS... assessment score test system into class II (special controls) under section 513(f)(2) of the Federal Food... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042) Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability AGENCY: Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0792] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0490] Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0305] Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0742 (formerly Docket No. 1999D-4396)] Draft Guidance for Clinical Investigators, Industry, and FDA Staff...: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff... Administration (FDA) is announcing the availability of the guidance entitled ``Center for Devices and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0530... Program and Meetings With FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-24
... Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for... Guidance for Industry and FDA Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for... and FDA Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (OMB...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-02
...] Draft Guidance for Industry and FDA Staff: Processing/ Reprocessing Medical Devices in Health Care... Devices in Health Care Settings: Validation Methods and Labeling.'' The recommendations in this guidance... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-18
... Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k... for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k... Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k)] Submissions--0910-NEW...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-03
...] Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug... and FDA staff entitled ``Glass Syringes for Delivering Drug and Biological Products: Technical... supplemental data are necessary for FDA to ensure the safe and effective use of glass syringes that comply with...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0590] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-23
...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' FDA is issuing this guidance to inform industry and Agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for artificial pancreas systems.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0324..., FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business... Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of...
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Agenda: EDRN FDA Education Workshop — EDRN Public Portal
The purpose of this workshop was to open dialogue between FDA staff that provide oversight for review of in vitro diagnostic applications and EDRN scientists currently performing clinical validation studies on cancer biomarkers. Issues related to FDA review of diagnostic tests were presented by FDA personnel. Representatives from EDRN provided details on supporting data of their validation studies and the resources developed within EDRN to facilitate such research for FDA compliance. The agenda provided here provides links to the presentations by each speaker.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0530... Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0324... Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User...: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0530... Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Withdrawal... a Food and Drug Administration (FDA) notice that published in the Federal Register of December 11...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0324...; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small...: The Food and Drug Administration (FDA) is announcing that a collection of information entitled...
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76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-06
...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. This draft guidance is not final nor is it in effect at this time.
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FDA Response to the Fukushima Dai-ichi Nuclear Power Facility Incident
... products from Japan. This means that whole shipping containers are screened by CBP. FDA field staff also ... by consumers or doctors claiming amazing results; limited availability and advance payment requirements; promises of no-risk, ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-25
... approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a... approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a... fulfilled in order for a sponsor to utilize the migration study approach in support of the change. The FDA...
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2002-01-14
The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA" as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information submitted in a reclassification petition from the International Society for Laboratory Hematology (ISLH), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997.
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Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.
1998-11-03
The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0776] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... based upon estimates by FDA administrative and technical staff who: (1) Are familiar with the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-22
... Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0114...
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21 CFR 880.5440 - Intravascular administration set.
Code of Federal Regulations, 2012 CFR
2012-04-01
...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...
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21 CFR 880.5440 - Intravascular administration set.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...
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21 CFR 880.5440 - Intravascular administration set.
Code of Federal Regulations, 2013 CFR
2013-04-01
...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...
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21 CFR 880.5440 - Intravascular administration set.
Code of Federal Regulations, 2014 CFR
2014-04-01
...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-12
...] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters... a draft guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' Dear Health Care Provider (DHCP) Letters are correspondence...
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2007-02-01
The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container." FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-09
... of Special Health Issues, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD... between health professional organizations and FDA staff. The Office of Special Health Issues serves as a... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-18
... requirements in high and maximum biocontainment, scientists working in this environment and FDA staff who will...] Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments... Containment Environments (U24).'' In this FOA, FDA announces its intention to accept and consider a single...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-03
... all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationand...),'' from CDRH you may either send an e-mail request to [email protected] to receive an electronic copy of... guidance describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-14
... Administration (FDA) is classifying the endovascular suturing system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance..., or FDA issues an order finding the device to be substantially equivalent, in accordance with section...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-06
...] Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information...
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76 FR 76168 - Regulatory Site Visit Training Program
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0824... routine manufacturing practices and to give CBER staff a better understanding of the biologics industry... quality of its regulatory efforts and interactions, by providing CBER staff with a better understanding of...
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FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster
By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-26
... http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsand...] (formerly 1999D-4396) Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-15
... of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza... of Influenza Viruses.'' FDA is issuing this guidance to inform industry and Agency staff of its... diagnostic devices intended for the detection or detection and differentiation of influenza viruses. DATES...
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76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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76 FR 69272 - Gayle Rothenberg: Debarment Order
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-08
... this conviction is as follows: Dr. Rothenberg was a physician licensed by the State of Texas as a... injections. From February to September 2004, Dr. Rothenberg and her office manager caused staff members to... was not approved by FDA. Dr. Rothenberg informed staff members that a new BOTOX product would be used...
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Legal considerations for social media marketing by pharmaceutical industry.
Yang, Y Tony; Chen, Brian
2014-01-01
Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0431] Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No... entitled ``Civil Money Penalties and No- Tobacco-Sale Orders for Tobacco Retailers.'' This guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1083] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1083] Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers... the guidance entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability AGENCY: Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-22
... intends to provide the underlying principles to determine the type of marketing submission that may be... industry and FDA staff on the underlying principles to determine the type of marketing submission that may... Modifications to a Combination Product Approved Under Certain Marketing Applications; Availability AGENCY: Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data; Availability AGENCY: Food and Drug Administration...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-15
... medical device for its intended use. Evidence from one or more pivotal clinical studies generally serves... some cases, a PMA may include multiple studies designed to answer different scientific questions. The... studies intended to support premarket submissions for medical devices and for FDA staff who review those...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0469] Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-26
...] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion... the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification... this issue of the Federal Register, FDA is announcing a public meeting regarding external infusion...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-10
...] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray... guidance entitled ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This draft... premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA...
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Standards for Lithotripter Performance
NASA Astrophysics Data System (ADS)
Schultheiss, Reiner; Doerffel, Michael
2008-09-01
Standards for lithotripsy have been developed by the International Electrotechnical Commission (IEC) and the FDA. In addition to the existing regulations and norms for the manufacturers, special standards were developed to address a treatment method developed in the early 1980's using extracorporeal shock waves. Initially, the FDA regulated the premarket approval process for lithotripters as a Class III device but reclassified lithotripters in 2000 to a Class II device. The corresponding guidance document for showing the substantial equivalence of new devices with predicate devices will be described in detail. The FDA guidance document is very useful in helping device manufacturers: (i) develop technical performance testing for a shock wave lithotripter within the parameters of an FDA submission, and (ii) conduct clinical performance testing via at least one clinical confirmation study with a small number of subjects. Unfortunately although the submitted data are available at the FDA they are not available in the marketplace and this causes difficulties for physicians in deciding which device to use. The results of the technical performance testing of the LithoGold™ are provided.
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ERIC Educational Resources Information Center
Albaqshi, Amani Mohammed H.
2017-01-01
Functional Data Analysis (FDA) has attracted substantial attention for the last two decades. Within FDA, classifying curves into two or more categories is consistently of interest to scientists, but multi-class prediction within FDA is challenged in that most classification tools have been limited to binary response applications. The functional…
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2007-11-30
The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.
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2010-11-05
The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0431] Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and... guidance entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-06
...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0429] Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Heinzelman, K M; Mansfield, W G
This document evaluates the expected radiation dose due to the consumption of several specific food classes (dairy, meat, produce, etc.) contaminated with specific radionuclides, and relates concentration levels in food to the detection abilities of typical aboratory analysis/measurement methods. The attached charts present the limiting organ dose as a function of the radionuclide concentration in a particular food class, and allow the user to compare these concentrations and doses to typical analytical detection apabilities. The expected radiation dose depends on several factors: the age of the individual; the radionuclide present in the food; the concentration of the radionuclide in themore » food; and the amount of food consumed. Food consumption rates for individuals of various ges were taken from the 1998 United States Food and Drug Administration (FDA) document, Accidental Radioactive Contamination of HUman Food and Animal Feeds: Recommendations for State and Local Agencies. In that document, the FDA defines the erived Intervention Level (DIL), which is the concentration of a particular radionuclide in food that if consumed could result in an individual receiving a radiation dose exceeding the Protection Action Guide (PAG) thresholds for intervention. This document also resents odified, food class specific DIL, which is calculated using a somewhat modified version of the FDA's procedure. This document begins with an overview of the FDA's DIL calculation, followed by a description of the food class specific DIL calculations, and finally charts of the radiation dose per radioactivity concentration for several food class/radionuclide combinations.« less
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2003-06-02
The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-02
... Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research... CDRH and CBER and have been compiled into checklists for use by FDA review staff. In the Federal... do so by using the Internet. A search capability for all CDRH guidance documents is available at http...
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The Center for Devices and Radiological health: an update.
Donawa, M
2001-12-01
At a recent medical device conference, Dr. David Feigal, the Director of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) stated that one-third of the CDRH staff will retire in five years. This is only one of many challenges that the Center faces.This article discusses key factors shaping current FDA device policies and programmes, the CDRH strategic plan, the continuing importance of the standards programme, and CDRH harmonisation activities.
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Regulatory aspects of noninvasive glucose measurements.
Gutman, Steve; Bernhardt, Patricia; Pinkos, Arleen; Moxey-Mims, Marva; Knott, Thomas; Cooper, Jean
2002-01-01
The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the Act) established three regulatory classes for medical devices. Section 513 of the Act specifies three classes based upon the degree of control and Food and Drug Administration (FDA) oversight that is necessary to assure that the various types of devices are safe and effective. High-risk devices are placed into the most regulated device class, Class III. Under Section 515 of the Act, all devices placed in Class III are subject to premarket approval (PMA) requirements. PMA by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Advisory panel review is required of virtually all original submissions. Manufacturing facilities of devices requiring PMA approval are also subject to preapproval inspection to assure data integrity and compliance with good manufacturing practices. An approved PMA is granted for marketing a particular medical device for a particular intended use. FDA considers noninvasive and minimally invasive glucose devices that are intended to measure, monitor, or predict blood glucose levels in diabetics to be high-risk medical devices. These devices will have a significant potential impact on the medical care of people with diabetes. The technology offers potential improvements in the quality of life, enhanced blood glucose control through increased frequency of testing, or access to testing, in a broader range of patients. However, the technology is not yet well understood, and the information obtained from these devices is often different from the information that has been the traditional base for the management of diabetes. As a result, FDA requires both analytical and clinical studies to support the intended claims for these new devices.
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... is used to treat pneumonia caused by a fungus called Pneumocystis carinii. It is in a class ... may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
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Kesselheim, Aaron S; Wang, Bo; Franklin, Jessica M; Darrow, Jonathan J
2015-09-23
To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. Cohort study. FDA approved novel therapeutics between 1987 and 2014. Publicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA's four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review. Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not. The FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction). In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs should be strictly limited to drugs providing noticeable clinical advances, this trend is being driven by drugs that are not first in class and thus potentially less innovative. © Kesselheim et al 2015.
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FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster
By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.
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Fixed-dose combination and single active ingredient drugs: a comparative cost analysis.
Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique
2016-01-01
Fixed-dose combination (FDC) drugs are formulations of two or more active ingredients. To assess the pricing structure and price difference of all US FDA-approved FDCs and single drugs included in the combination. Data were collected from the FDA Orange Book and Drugs@FDA. Average Wholesale Price (AWP) unit price data were derived from The Red Book. The FDA approved 117 FDC. The average AWP difference percentage between the FDC and the sum of the single drugs in the FDC is 84.9 ± 26.2%, and varied by therapeutic class (p < 0.001). The FDC AWP averaged 83.3 ± 23.4% of the single drug AWP sum when there are no generics, and 95.1 ± 42.3% (p < 0.01) when there are two generic single active ingredients in the FDC. The price difference between FDC and single active ingredients in the combination is correlated with the therapeutic class, the year of FDC approval, and the number of single ingredients in the combination that have generics.
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Reed, Terrie L; Kaufman-Rivi, Diana
2010-01-01
The broad array of medical devices and the potential for device failures, malfunctions, and other adverse events associated with each device creates a challenge for public health device surveillance programs. Coding reported events by type of device problem provides one method for identifying a potential signal of a larger device issue. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Event Problem Codes that are used to report adverse events previously lacked a structured set of controls for code development and maintenance. Over time this led to inconsistent, ambiguous, and duplicative concepts being added to the code set on an ad-hoc basis. Recognizing the limitation of its coding system the FDA set out to update the system to improve its usefulness within FDA and as a basis of a global standard to identify important patient and device outcomes throughout the medical community. In 2004, FDA and the National Cancer Institute (NCI) signed a Memorandum of Understanding (MOU) whereby NCI agreed to provide terminology development and maintenance services to all FDA Centers. Under this MOU, CDRH's Office of Surveillance and Biometrics (OSB) convened a cross-Center workgroup and collaborated with staff at NCI Enterprise Vocabulary Service (EVS) to streamline the Patient and Device Problem Codes and integrate them into the NCI Thesaurus and Meta-Thesaurus. This initiative included many enhancements to the Event Problem Codes aimed at improving code selection as well as improving adverse event report analysis. LIMITATIONS & RECOMMENDATIONS: Staff resources, database concerns, and limited collaboration with external groups in the initial phases of the project are discussed. Adverse events associated with medical device use can be better understood when they are reported using a consistent and well-defined code set. This FDA initiative was an attempt to improve the structure and add control mechanisms to an existing code set, improve analysis tools that will better identify device safety trends, and improve the ability to prevent or mitigate effects of adverse events associated with medical device use.
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Real-World Evidence, Public Participation, and the FDA.
Schwartz, Jason L
2017-11-01
For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.
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The nightmare of FDA clearance/approval to market: perception or reality?
Tylenda, C A
1996-09-01
Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtaining permission to market medical devices in the United States.
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76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-22
...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-29
... document describes FDA's recommendations concerning 510(k) submissions for various types of in vitro.... SUPPLEMENTARY INFORMATION: I. Background This draft guidance includes recommendations concerning 510(k...
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76 FR 51039 - Statement of Organizations, Functions, and Delegations of Authority
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-17
... Bioequivalence II, Division of Microbiology, Division of Clinical Review, and Division of Chemistry IV. In...FDA/ReportsManualsForms/StaffManualGuides/default.htm . Dated: August 10, 2011. Leslie Kux, Acting...
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FDA's regulation of tanning beds: how much heat?
Knapp, Veronica
2011-01-01
This paper considers the problem of indoor tanning bed use by teenagers. The paper explores FDA's current authority to regulate tanning lamps as Class I medical devices, concluding that FDA's authority is poorly tailored to affect teenagers' repeated use of these products. An outright ban is unlikely; therefore, the best available options are to regulate access by minors and to amend the warning label requirements to reflect the current state of knowledge about the risks of tanning bed use.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-08
... Guidance Document: Labeling for Natural Rubber Latex Condoms AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0492...
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78 FR 76059 - New Animal Drugs for Use in Animal Feeds; Bambermycins
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-16
.... FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Bambermycins AGENCY: Food and Drug... amending the animal drug regulations to remove dairy replacement heifers from the pasture cattle class for....gov . SUPPLEMENTARY INFORMATION: FDA has noticed that the animal drug regulations for bambermycins...
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77 FR 36951 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-20
... into class II (special controls). FDA is proposing this reclassification on its own initiative based on... categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II...
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Hearing Aids and Personal Sound Amplifiers: Know the Difference
... Devices and Personal Sound Amplification Products - Guidance for Industry and FDA Staff (PDF - 42KB) More in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products ...
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... HIV/AIDS-related drugs for that condition. OK Filters Approval: What's this? FDA-Approved Investigational Class: What's ... Encephalitis Tuberculosis Varicella-Zoster Virus Diseases Update Loading... Filter by approval status, drug class, and condition Browse ...
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NASA Astrophysics Data System (ADS)
Agrawal, Anant; Gavrielides, Marios A.; Weininger, Sandy; Chakrabarti, Kish; Pfefer, Joshua
2008-02-01
For a number of years, phantoms have been used to optimize device parameters and validate performance in the primary medical imaging modalities (CT, MRI, PET/SPECT, ultrasound). Furthermore, the FDA under the Mammography Quality Standards Act (MQSA) requires image quality evaluation of mammography systems using FDA-approved phantoms. The oldest quantitative optical diagnostic technology, pulse oximetry, also benefits from the use of active phantoms known as patient simulators to validate certain performance characteristics under different clinically-relevant conditions. As such, guidance provided by the FDA to its staff and to industry on the contents of pre-market notification and approval submissions includes suggestions on how to incorporate the appropriate phantoms in establishing device effectiveness. Research at the FDA supports regulatory statements on the use of phantoms by investigating how phantoms can be designed, characterized, and utilized to determine critical device performance characteristics. These examples provide a model for how novel techniques in the rapidly growing field of optical diagnostics can use phantoms during pre- and post-market regulatory testing.
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Classification of Stellar Spectra with Fuzzy Minimum Within-Class Support Vector Machine
NASA Astrophysics Data System (ADS)
Zhong-bao, Liu; Wen-ai, Song; Jing, Zhang; Wen-juan, Zhao
2017-06-01
Classification is one of the important tasks in astronomy, especially in spectra analysis. Support Vector Machine (SVM) is a typical classification method, which is widely used in spectra classification. Although it performs well in practice, its classification accuracies can not be greatly improved because of two limitations. One is it does not take the distribution of the classes into consideration. The other is it is sensitive to noise. In order to solve the above problems, inspired by the maximization of the Fisher's Discriminant Analysis (FDA) and the SVM separability constraints, fuzzy minimum within-class support vector machine (FMWSVM) is proposed in this paper. In FMWSVM, the distribution of the classes is reflected by the within-class scatter in FDA and the fuzzy membership function is introduced to decrease the influence of the noise. The comparative experiments with SVM on the SDSS datasets verify the effectiveness of the proposed classifier FMWSVM.
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Co-streaming classes: a follow-up study in improving the user experience to better reach users.
Hayes, Barrie E; Handler, Lara J; Main, Lindsey R
2011-01-01
Co-streaming classes have enabled library staff to extend open classes to distance education students and other users. Student evaluations showed that the model could be improved. Two areas required attention: audio problems experienced by online participants and staff teaching methods. Staff tested equipment and adjusted software configuration to improve user experience. Staff training increased familiarity with specialized teaching techniques and troubleshooting procedures. Technology testing and staff training were completed, and best practices were developed and applied. Class evaluations indicate improvements in classroom experience. Future plans include expanding co-streaming to more classes and on-going data collection, evaluation, and improvement of classes.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0492... Request; Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-02
... in an IND. In addition, organizational and editorial revisions were made to improve clarity. The...). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights...
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A roundtable discussion: home healthcare-not a hospital in the home.
Logan, Mary K; Parker, Chuck; Gardner-Bonneau, Daryle; Treu, Denny; Keller, James; Winstel, Lisa; Weick-Brady, Mary; Kramer, Nancy; Cyrus, Reginald; Thiel, Scott; Lewis, Vicki R; Rogers, Wendy
2013-01-01
Home healthcare is vital for a large percentage of the population. According to data from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), 7 million people in the United States receive home healthcare annually. The use of medical devices in the home and other nonclinical environments is increasing dramatically. By the year 2050, an estimated 27 million people will need continuing care in the home or in the community and not in a controlled clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH) regulates medical devices, but that regulatory authority alone is not enough to ensure safe and effective use of devices in the home. To address these and other issues, AAMI and FDA will co-host a summit on healthcare technology in nonclinical settings Oct. 9-10, 2013.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-05
... [Docket No. FDA-2009-N-0493] RIN 0910-ZA37 Neurological and Physical Medicine Devices; Designation of... proposing to amend certain neurological device and physical medicine device regulations to establish special..., FDA is proposing to amend the physical medicine devices regulation at Sec. 890.5850 (21 CFR 890.5850...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-13
...-NEW) Resistance of parasites to one or more of the major classes of FDA approved antiparasitic drugs... drugs at the same time on the development of resistance to these drugs. The results from this survey... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0307...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-19
... specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the draft special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In... regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-08
... for Devices and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov...'' from CDRH, you may either send an email request to [email protected] to receive an electronic copy of...
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Gnanasakthy, Ari; DeMuro, Carla; Clark, Marci; Haydysch, Emily; Ma, Esprit; Bonthapally, Vijayveer
2016-06-01
To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. FDA Drug Approval Reports by Month were reviewed to obtain the number of new molecular entities and biologic license applications approved from 2010 to 2014. Drugs approved by the FDA OHOP during this period were selected for further review, focusing on brand and generic name; approval date; applicant; indication; PRO labeling describing treatment benefit, measures, end point status, and significant results; FDA reviewer feedback on PRO end points; and study design of registration trials. First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieved for selected oncology drugs from 2011 to 2014. Descriptive analyses were performed by using Microsoft Excel 2010. Of 160 drugs approved by the FDA (2010-2014), 40 were approved by OHOP. Three (7.5%) of the 40 received PRO-related labeling (abiraterone acetate, ruxolitinib phosphate, and crizotinib). Compared with nononcology drugs (2011-2014), oncology drugs were more likely to be orphan and first in class. The majority of oncology drug reviews by FDA were fast track, priority, or accelerated. Although symptoms and functional decrements are common among patients with cancer, PRO labeling is rare in the United States, likely because of logistical hurdles and oncology study design. Recent developments within the FDA OHOP to capture PROs in oncology studies for the purpose of product labeling are encouraging. © 2016 by American Society of Clinical Oncology.
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Blood component recalls in the United States.
Ramsey, G; Sherman, L A
1999-05-01
United States blood suppliers are required to recall marketed blood components later found to be in violation of Food and Drug Administration (FDA) regulations for safety, purity, and potency. Many recalled units have already been transfused. Analysis of the frequency and nature of blood component recalls would be useful for blood suppliers, transfusion services, and physicians. Each blood component recall in the weekly FDA Enforcement Report from 1990 through 1997 was examined for the number of units, recall reason, and hazard class. Units for manufacturing were excluded. In 8 years, an estimated 241,800 blood components were recalled, or approximately 1 in 700 units available to US hospitals. Eighty-eight percent of recalled units were in 22 large recalls of over 1000 units each. The most common reasons were incorrect testing for syphilis (57% of units) or viral markers (19%), reactive or previously reactive donor viral markers (6-11%), and inadequate donor-history screening (4%). Twelve units were in the FDA's highest hazard Class I, 24 percent were in Class II, and 76 percent were in Class III. Over 43,900 units had HIV-related problems, but only 3 units involved HIV transmission. Large recalls have declined since peaking in 1995, but units in small recalls increased 116 percent in 1997 over the previous 7-year average. Although high-risk recalls are rare, many blood component recalls pose medical concerns for physicians and patients. The recent decline in large recalls may be due to increased FDA oversight, stricter accreditation standards for quality improvement, and more centralized donor testing in large specialized laboratories. However, smaller recalls, which involve nearly all blood suppliers, were sharply higher in 1997.
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The use of cimetidine in hospitalized patients.
Kopala, L
1984-01-01
Cimetidine is the most commonly prescribed drug in North America. A clinical review was conducted to identify physicians' prescribing habits. From September 1, 1981 to March 31, 1982, the charts were reviewed of 50 patients receiving cimetidine in an isolated coastal community hospital in British Columbia. It was discovered that physicians prescribed the drug for reasons approved by the Food and Drug Administration (FDA) only 14% of the time. The FDA guidelines approve cimetidine for duodenal ulcer, Zollinger-Ellison syndrome, and other hypersecretory states. A literature review was conducted, and guidelines on prescribing cimetidine were given to all members of the hospital's medical staff.
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Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.
Bradford, W David; Kleit, Andrew N
2015-07-01
Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.
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Cardot, J-M; Garcia Arieta, A; Paixao, P; Tasevska, I; Davit, B
2016-07-01
The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain a biowaiver for immediate-release oral dosage forms based on the Biopharmaceutics Classification System (BCS). This review compares the present FDA BCS biowaiver approach, with the existing European Medicines Agency (EMA) approach, with an emphasis on similarities, difficulties, and shared challenges. Some specifics of the current EMA BCS guideline are compared with those in the recently published draft US-FDA BCS guideline. In particular, similarities and differences in the EMA versus US-FDA approaches to establishing drug solubility, permeability, dissolution, and formulation suitability for BCS biowaiver are critically reviewed. Several case studies are presented to illustrate the (i) challenges of applying for BCS biowaivers for global registration in the face of differences in the EMA and US-FDA BCS biowaiver criteria, as well as (ii) challenges inherent in applying for BCS class I or III designation and common to both jurisdictions.
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Federal regulation of vision enhancement devices for normal and abnormal vision
NASA Astrophysics Data System (ADS)
Drum, Bruce
2006-09-01
The Food and Drug Administration (FDA) evaluates the safety and effectiveness of medical devices and biological products as well as food and drugs. The FDA defines a device as a product that is intended, by physical means, to diagnose, treat, or prevent disease, or to affect the structure or function of the body. All vision enhancement devices fulfill this definition because they are intended to affect a function (vision) of the body. In practice, however, FDA historically has drawn a distinction between devices that are intended to enhance low vision as opposed to normal vision. Most low vision aids are therapeutic devices intended to compensate for visual impairment, and are actively regulated according to their level of risk to the patient. The risk level is usually low (e.g. Class I, exempt from 510(k) submission requirements for magnifiers that do not touch the eye), but can be as high as Class III (requiring a clinical trial and Premarket Approval (PMA) application) for certain implanted and prosthetic devices (e.g. intraocular telescopes and prosthetic retinal implants). In contrast, the FDA usually does not actively enforce its regulations for devices that are intended to enhance normal vision, are low risk, and do not have a medical intended use. However, if an implanted or prosthetic device were developed for enhancing normal vision, the FDA would likely decide to regulate it actively, because its intended use would entail a substantial medical risk to the user. Companies developing such devices should contact the FDA at an early stage to clarify their regulatory status.
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Guide to preemption of state-law claims against Class III PMA medical devices.
Whitney, Daniel W
2010-01-01
There is a perception that the express preemption holding of the Supreme Court in Riegel v. Medtronic, 552 U.S. 312(2008), immunizes medical device manufacturers from common law personal injury actions involving Class III devices that received FDA clearance under a premarket approval application (PMA). In the aftermath of Riegel, many lawsuits involving Class III PMA devices have been dismissed by district courts applying the new heightened pleading standard of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Other lawsuits involving Class III PMA devices premised on fraud-on-FDA have been dismissed based on the implied preemption holding of the Supreme Court in Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). When these decisions are carefully analyzed together with Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which found no preemption regarding a Class III device receiving FDA clearance through the 510(k) mechanism, it is apparent that the preemption defense does not apply universally to Class III PMA devices. The overall methodology for framing a non-preempted claim is to first identify conduct which violated the PMA or other specific requirements related to safety or efficacy. If such conduct can also be stated in terms of a breach of a parallel common law duty (e.g, failure to warn under strict liability or negligence, manufacturing defect or breach of warranty), then it would appear the claim is not preempted. Alternatively, regardless of a specific violation, common law remedies are not preempted by general CGMP requirements.
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[Effects of Drugs Given During Pregnancy and Lactation on the Unborn Child and Neonate.
ERIC Educational Resources Information Center
Kelsey, Frances O.
This symposium presentation outlines the activity of the Food and Drug Administration (FDA) in regulating the use during pregnancy and lactation of drugs which affect the fetus and neonate. When presented with an unexpected adverse effect of a drug or of a class of drugs, the FDA can take several steps. These steps include ordering total removal…
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Enhancing the incorporation of the patient's voice in drug development and evaluation.
Chalasani, Meghana; Vaidya, Pujita; Mullin, Theresa
2018-01-01
People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focused Drug Development (PFDD) initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. PFDD meetings are unique among FDA public meetings, with a format designed to engage patients and elicit their perspectives on two topic areas: (1) the most significant symptoms of their condition and the impact of the condition on daily life; and, (2) their current approaches to treatment. FDA has conducted 24 disease-specific PFDD meetings to date. The lessons learned from PFDD meetings range from experiences common across rare diseases to more disease specific experiences that matter most to patients. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Patient-focused drug development is an ongoing effort and FDA looks forward to the next steps in advancing the science and the utilization of patient input throughout drug development and evaluation. The U.S. Food and Drug Administration (FDA) has multiple mechanisms for its regulators and staff to interact with patients -- but none quite like its novel Patient-Focused Drug Development (PFDD) initiative. FDA established the PFDD initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. Since the initiative's inception in 2012, FDA has held 24 PFDD meetings, covering a range of disease areas and hearing directly from thousands of patients and caregivers. FDA's PFDD meetings have also provided key stakeholders, including patient advocates, researchers, drug developers, healthcare providers, and other government officials, an opportunity to hear the patient's voice. The lessons learned include but are not limited to specific experiences that matter most to patients, patient perspectives on meaningful treatment benefits and how patients want to be engaged in the drug development process. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Further enhancing the incorporation of the patient's voice in drug development and evaluation continues to be a priority for FDA.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0776] Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification... staff who: (1) Are familiar with the requirements for submission of a reclassification petition, (2...
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How Much Do We Know about the Most Common Medicines Used during Pregnancy?
... some medications taken during pregnancy. Technical expertise: CDC works with staff from the U.S. Food and Drug Administration (FDA) and other professionals to help conduct studies on the effects of medication use during pregnancy and ways to prevent harmful effects. ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug...
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Preparing Writing Centers and Tutors for Literacy Mediation for Working Class Campus-Staff
ERIC Educational Resources Information Center
Oslund, Christy M.
2011-01-01
This study grew out of the realization that implicit literacy expectations between working class United Auto Workers (UAW) staff and professional class staff were complicating the filling out and filing of a position audit form. Professional class supervisors had designed the form as a measure of fairness, in that each UAW employee on campus was…
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The Use of Cimetidine in Hospitalized Patients
Kopala, Lili
1984-01-01
Cimetidine is the most commonly prescribed drug in North America. A clinical review was conducted to identify physicians' prescribing habits. From September 1, 1981 to March 31, 1982, the charts were reviewed of 50 patients receiving cimetidine in an isolated coastal community hospital in British Columbia. It was discovered that physicians prescribed the drug for reasons approved by the Food and Drug Administration (FDA) only 14% of the time. The FDA guidelines approve cimetidine for duodenal ulcer, Zollinger-Ellison syndrome, and other hypersecretory states. A literature review was conducted, and guidelines on prescribing cimetidine were given to all members of the hospital's medical staff. PMID:21283494
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0258] Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-28
... Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug... for 11 neurological and physical medicine devices. FDA is reopening the comment period to allow... announcing the availability of draft special controls guidance documents for 11 neurological and physical...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-07
... assessment. In some cases, a PMA may include multiple studies designed to answer different scientific... designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles...
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21 CFR 21.41 - Processing of requests.
Code of Federal Regulations, 2010 CFR
2010-04-01
... PRIVACY Procedures for Notification of and Access to Records in Privacy Act Record Systems § 21.41... consult with the individual concerning the appropriate treatment of the request. (c) The FDA Privacy Act Coordinator (HFI-30) in the Freedom of Information Staff shall be responsibile for the handling of Privacy Act...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1558... Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-25
... things, dated copies of advertisements, dated catalog pages, and dated promotional material. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices... manufacturer provide evidence that may include, among other things, dated copies of advertisements, dated...
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Gastroenterology-urology devices; reclassification of implanted blood access devices. Final rule.
2014-07-25
The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.
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The FDA alert on suicidality and antiepileptic drugs: Fire or false alarm?
Hesdorffer, Dale C; Kanner, Andres M
2009-05-01
In January 2008, the U.S. Food and Drug Administration (FDA) issued an alert about an increased risk for suicidality in 199 clinical trials of 11 antiepileptic drugs (AEDs) for three different indications, including epilepsy. An advisory panel voted against a black-box warning on AED labels, and the FDA has accepted this recommendation. We discuss three potential problems with the alert. First, adverse event data were used rather than systematically collected data. Second, the 11 drugs grouped together as a single class of AEDs have different mechanisms of action and very different relative risks, many of which were not statistically significant and some of which were smaller than one. These facts suggest that they should not be grouped as a class. Third, the risk of adverse effects from uncontrolled seizures almost certainly outweighs the small risk of suicidality. We place our comments in the context of a review of the literature on suicidality and depression in epilepsy and the sparse literature on AEDs and suicidality. We recommend that all patients with epilepsy be routinely evaluated for depression, anxiety, and suicidality, and that future clinical trials include validated instruments to systematically assess these conditions to determine whether the possible signal observed by the FDA is real.
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Wang, Haipeng; Tang, Chengxiang; Zhao, Shichao; Meng, Qingyue; Liu, Xiaoyun
2017-09-22
Background : The lower job satisfaction of health-care staff will lead to more brain drain, worse work performance, and poorer health-care outcomes. The aim of this study was to identify patterns of job satisfaction among health-care staff in rural China, and to investigate the association between the latent clusters and health-care staff's personal and professional features; Methods : We selected 12 items of five-point Likert scale questions to measure job satisfaction. A latent-class analysis was performed to identify subgroups based on the items of job satisfaction; Results : Four latent classes of job satisfaction were identified: 8.9% had high job satisfaction, belonging to "satisfied class"; 38.2% had low job satisfaction, named as "unsatisfied class"; 30.5% were categorized into "unsatisfied class with the exception of interpersonal relationships"; 22.4% were identified as "pseudo-satisfied class", only satisfied with management-oriented items. Low job satisfaction was associated with specialty, training opportunity, and income inequality. Conclusions : The minority of health-care staff belong to the "satisfied class". Three among four subgroups are not satisfied with income, benefit, training, and career development. Targeting policy interventions should be implemented to improve the items of job satisfaction based on the patterns and health-care staff's features.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-15
... availability of the draft guidance document entitled ``Factors to Consider When Making Benefit-Risk... versus its probable risk. This draft guidance sets out the factors FDA considers when making this... factors to consider when making benefit-risk determinations in medical device premarket review. It does...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-20
... enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology... profiles and for which it believes 510(k) review is not necessary to assure safety and effectiveness. While FDA intends to exempt these devices from the 510(k) requirement through rulemaking that would...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-05
... Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION... controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft... stimulator device achieves ``aesthetic effects through physical change to the structure of the body'' as well...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-18
... facilities into commercial sites and academic sites, and questioned whether the data are a fair... dedicated to regulatory compliance, whereas the individual sites, like the academic labs, must perform the same functions with a much smaller staff. The comment said that FDA's burden estimates for academic...
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41 CFR 101-42.1102-5 - Drugs, biologicals, and reagents other than controlled substances.
Code of Federal Regulations, 2012 CFR
2012-07-01
... UTILIZATION AND DISPOSAL 42-UTILIZATION AND DISPOSAL OF HAZARDOUS MATERIALS AND CERTAIN CATEGORIES OF PROPERTY... are subject to the provisions of § 101-42.1102-3. (a) Utilization requirements. Excess drugs... Scientific Coordination Staff, ACFA-CF-30, located in the appropriate FDA district office, of surplus...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-13
... for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave... INFORMATION CONTACT: For information concerning the guidance as it relates to devices regulated by CDRH: Mary... Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/Medical...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-28
... Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New... CONTACT: For devices regulated by CDRH: Ruth Fischer, Center for Devices and Radiological Health, Food and... search capability is available for all CDRH guidance documents at http://www.fda.gov/MedicalDevices...
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2014-01-23
The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Fujikawa, Yuuta; Nampo, Taiki; Mori, Masaya; Kikkawa, Manami; Inoue, Hideshi
2018-03-01
Pi class glutathione S-transferase (GSTP1) is highly expressed in various cancerous cells and pre-neoplastic legions, where it is involved in apoptotic resistance or metabolism of several anti-tumour chemotherapeutics. Therefore, GSTP1 is a marker of malignant and pre-malignant cells and is a promising target for visualization and drug development. Here we demonstrate that fluorescein diacetate (FDA), a fluorescent probe used for vital staining, is a fluorescently activated by esterolytic activity of human GSTP1 (hGSTP1) selectively among various cytosolic GSTs. Fluorescence activation of FDA susceptible to GST inhibitors was observed in MCF7 cells exogenously overexpressing hGSTP1, but not in cells overexpressing hGSTA1 or hGSTM1. Inhibitor-sensitive fluorescence activation was also observed in several cancer cell lines endogenously expressing GSTP1, suggesting that GSTP1 is involved in FDA esterolysis in these cells. Among the FDA derivatives examined, FOMe-Ac, the acetyl ester of fluorescein O-methyl ether, was found to be a potential reporter for GSH-dependent GSTP1 activity as well as for carboxylesterase activity. Since GSTP1 is highly expressed in various types of cancer cells compared to their normal counterparts, improving the fluorogenic substrates to be more selective to the esterolysis activity of GSTP1 rather than carboxylesterases should lead to development of tools for detecting GSTP1-overexpressing cancer cells and investigating the biological functions of GSTP1. Copyright © 2017 Elsevier B.V. All rights reserved.
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2000-04-07
The Food and Drug Administration (FDA) is reclassifying over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.
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Revisiting "the origins of compulsory drug prescriptions".
Marks, H M
1995-01-01
It has been argued that today's prescription drug market originated in the arbitrary acts of the US Food and Drug Administration (FDA), which in 1938 issued regulations creating a class of drugs that could be sold by prescription only. On the basis of the FDA's administrative records, I argue that the 1938 regulations on prescription drug labeling were initiated by industry and then agreed to by the FDA; that contemporaries understood and accepted the reasons for restricting the use of certain drugs; and that the subsequent evolution of these regulations is best understood as an FDA effort to limit industry abuses of the prescription labeling system. This decade-long war of position ended when drug manufacturers persuaded the US Congress to enshrine their version of prescription labeling in law in a highly politicized struggle over government's role in the economy. Images FIGURE 1 PMID:7832245
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Validation of gamma irradiator controls for quality and regulatory compliance
NASA Astrophysics Data System (ADS)
Harding, Rorry B.; Pinteric, Francis J. A.
1995-09-01
Since 1978 the U.S. Food and Drug Administration (FDA) has had both the legal authority and the Current Good Manufacturing Practice (CGMP) regulations in place to require irradiator owners who process medical devices to produce evidence of Irradiation Process Validation. One of the key components of Irradiation Process Validation is the validation of the irradiator controls. However, it is only recently that FDA audits have focused on this component of the process validation. What is Irradiator Control System Validation? What constitutes evidence of control? How do owners obtain evidence? What is the irradiator supplier's role in validation? How does the ISO 9000 Quality Standard relate to the FDA's CGMP requirement for evidence of Control System Validation? This paper presents answers to these questions based on the recent experiences of Nordion's engineering and product management staff who have worked with several US-based irradiator owners. This topic — Validation of Irradiator Controls — is a significant regulatory compliance and operations issue within the irradiator suppliers' and users' community.
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21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... type of device is designed to achieve biological fixation to bone without the use of bone cement. This... bearing is rigidly secured to the metal tibial base plate. (b) Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-15
... control by other users with a similar medical device. Exposure to non-ionizing radiation Wireless... Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-06
...] Center for Devices and Radiological Health; Standard Operating Procedures for Network of Experts; Request... procedures (SOPs) for a new ``Network of Experts.'' The draft SOPs describe a new process for staff at the... FDA is announcing the availability of two draft SOPs, one entitled, ``Network of Experts--Expert...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-28
... ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH... submit related requests to CDRH and FDA. This draft guidance is not final nor is it in effect at this...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-20
... Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this... search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html... CDRH and CBER are implementing this provision of the law and providing public notice as required. The...
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75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-20
...-847-8149 to receive a hard copy. Please use the document number (1607). CDRH maintains an entry on the... personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device... capability for all CDRH guidance documents is available at http://www.fda.gov/medicaldevices...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-28
... Memorandum titled ``Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3,'' a... achieves its intended goals. In September 2009, FDA's Center for Devices and Radiological Health (CDRH... regarding the strengths and challenges associated with the 510(k) program. In August 2010, CDRH published...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-20
...] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Implanted Blood... blood access devices may comply with the requirement of special controls for class II devices. This...
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... Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the ... your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting ...
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... is in a class of medications called ovulatory stimulants. It works similarly to estrogen, a female hormone ... your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting ...
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Tanning lamps: health effects and reclassification by the Food and Drug Administration.
Ernst, Alexander; Grimm, Amanda; Lim, Henry W
2015-01-01
Tanning lamps have long been considered a class I medical device under regulation by the Food and Drug Administration (FDA). A growing body of research has repeatedly documented the association between elective indoor tanning and several negative health consequences. These accepted findings have prompted action by the FDA to officially reclassify tanning lamps as a class II medical device. The main purpose of this review is to update practitioners on the current state of tanning lamp classification and highlight the practical implications of this recent change. This information can be used by clinicians to easily reference this important action, and empower patients with a better understanding of the risks associated with indoor tanning. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
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2003-04-22
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).
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Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule.
2011-04-25
The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,'' which will serve as the special control for this device.
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... Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the ... your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting ...
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... including conjunctivitis (pink eye) and ulcers of the cornea. Ofloxacin is in a class of medications called ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...
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21 CFR 884.1185 - Endometrial washer.
Code of Federal Regulations, 2010 CFR
2010-04-01
... with negative pressure. This device is used to study endometrial cytology (cells). (b) Classification. Class II. The special controls for this device are: (1) FDA's: (i) “Use of International Organization...
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Mentored Research | Cancer Prevention Fellowship Program
The major activity for Cancer Prevention Fellows is mentored research. All fellows are expected to develop original scientific projects and to report their findings at scientific meetings and in leading journals. Fellows select preceptors, who guide and enrich the fellow’s experience, from skilled investigators across all NCI divisions or participating FDA centers. Over 100 NCI staff members have served as preceptors.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-27
... effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5... departments, and manufacturers of enteral feeding tubes regarding luer lock misconnections. FDA advised... for Enteral Applications,'' you may either send an email request to [email protected] to receive an...
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Preceptorships | Cancer Prevention Fellowship Program
The major activity for Cancer Prevention Fellows is mentored research. All fellows are expected to develop original scientific projects and to report their findings at scientific meetings and in leading journals. Preceptors who serve to guide and enrich each fellow's experience are selected from skilled investigators across all NCI divisions, participating FDA centers, or local academic institutions. Over 100 NCI staff members have served as preceptors.
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The new collaborative path in medical device development: the medical device innovation consortium.
Kampfrath, Thomas; Cotten, Steven W
2013-10-01
The United States medical device market is the world's largest with over $100 billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a Medical Device Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medical devices and their expertise can recognize unmet needs and contribute towards the acceleration of device development. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
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... www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.No matter your age, before you take an antidepressant, you, ... abdomen itching yellowing of the skin or eyes dark colored urine loss of appetite extreme tiredness or ...
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... www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.No matter your age, before you take an antidepressant, you, ... blue discoloration of the skin fever widened pupils (dark circles in the center of the eye) decreased ...
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... www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.No matter what your age, before you take an antidepressant, ... seeing things that do not exist) widened pupils (dark circles in the middle of the eyes) drowsiness ...
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... www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.No matter what your age, before you take an antidepressant, ... the skin or eyes, unusual bleeding or bruising, dark-colored urine, pain in the upper right part ...
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Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates.
Berndt, Ernst R; Gottschalk, Adrian H B; Philipson, Tomas J; Strobeck, Matthew W
2005-07-01
The development of new therapies is a crucial component of efforts to improve healthcare. Because drug development and FDA regulatory review have historically been lengthy and costly processes, the US Congress passed a series of legislative acts, beginning in 1992, known collectively as the Prescription Drug User Fee Acts (PDUFA), which sought to expedite the FDA drug-review process. Here, we review data on drug approvals and drug-approval times, both as a whole and by therapeutic class, which demonstrate that implementation of the PDUFAs led to substantial incremental reductions in approval times beyond what would have been observed in the absence of these legislative acts. In addition, our preliminary examination of the trends in the number of new molecular entity withdrawals, frequently used as a proxy to assess the FDA's safety record, suggests that the proportion of approvals ultimately leading to safety withdrawals prior to PDUFA and during PDUFA I and II were not statistically different.
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21 CFR 878.3720 - Tracheal prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The... include a device delivery system. (b) Classification. Class II. The special control for this device is FDA...
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21 CFR 878.3720 - Tracheal prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The... include a device delivery system. (b) Classification. Class II. The special control for this device is FDA...
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21 CFR 878.3720 - Tracheal prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The... include a device delivery system. (b) Classification. Class II. The special control for this device is FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-29
... request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for... capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/Device... Responses Response Total hours CDRH 3601 110 1 110 2 220 CBER 3601 4 1 4 2 8 Total Hours 228 \\1\\ There are...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-17
... Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver... request, or fax your request to CDRH at 301-847-8149. The draft guidance may also be obtained by mail by... using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-19
...; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...
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21 CFR 886.3920 - Aqueous shunt.
Code of Federal Regulations, 2013 CFR
2013-04-01
...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...
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21 CFR 886.3400 - Keratoprosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...
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21 CFR 886.3920 - Aqueous shunt.
Code of Federal Regulations, 2014 CFR
2014-04-01
...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...
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21 CFR 886.3400 - Keratoprosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...
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21 CFR 886.3920 - Aqueous shunt.
Code of Federal Regulations, 2012 CFR
2012-04-01
...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...
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21 CFR 886.3400 - Keratoprosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...
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21 CFR 886.3920 - Aqueous shunt.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...
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21 CFR 886.3920 - Aqueous shunt.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...
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21 CFR 886.3400 - Keratoprosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...
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21 CFR 886.3400 - Keratoprosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...
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Zhu, Xiuqing; Hu, Jinqing; Sun, Bin; Deng, Shuhua; Wen, Yuguan; Chen, Weijia; Qiu, Chang; Shang, Dewei; Zhang, Ming
2018-04-01
This study aims to compare the prevalence of unlicensed and off-label use of antipsychotics among child and adolescent psychiatric outpatients with guidelines proposed by the China Food and Drug Administration (CFDA) and the U.S. Food and Drug Administration (FDA), and to identify factors associated with inconsistencies between the two regulations. A retrospective analysis of 29,326 drug prescriptions for child and adolescent outpatients from the Affiliated Brain Hospital of Guangzhou Medical University was conducted. Antipsychotics were classified as "unlicensed" or "off-label use" according to the latest pediatric license information registered by the CFDA and the FDA or the package inserts of antipsychotics authorized by the CFDA or the FDA for the treatment of pediatric mental and behavioral disorders, respectively. Binary logistic regression analysis was performed to assess factors associated with inconsistencies between the two regulations. The total unlicensed use, according to the CFDA analysis, was higher than that found in the FDA analysis (74.14% vs. 22.04%, p < 0.001). However, the total off-label use, according to the FDA analysis, was higher than that found in the CFDA analysis (46.53% vs. 15.77%, p < 0.001). Antipsychotic drug classes, age group, number of diagnoses, and diagnosis of schizophrenia and schizotypal and delusional disorders were associated with inconsistent unlicensed use. Antipsychotic drug classes, age group, number of prescribed psychotropic drugs, gender, diagnosis of schizophrenia and schizotypal and delusional disorders, diagnosis of mood [affective] disorders, diagnosis of mental retardation, and diagnosis of psychological development disorders were associated with inconsistent off-label use. The difference in prevalence of total unlicensed and off-label use of antipsychotics between the two regulations was statistically significant. This inconsistency could be partly attributed to differences in pediatric license information and package inserts of antipsychotics. The results indicate a need for further clinical pediatric studies and better harmonization between agencies regarding antipsychotic used in pediatrics.
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MO-DE-BRA-04: Hands-On Fluoroscopy Safety Training with Real-Time Patient and Staff Dosimetry
DOE Office of Scientific and Technical Information (OSTI.GOV)
Vanderhoek, M; Bevins, N
Purpose: Fluoroscopically guided interventions (FGI) are routinely performed across many different hospital departments. However, many involved staff members have minimal training regarding safe and optimal use of fluoroscopy systems. We developed and taught a hands-on fluoroscopy safety class incorporating real-time patient and staff dosimetry in order to promote safer and more optimal use of fluoroscopy during FGI. Methods: The hands-on fluoroscopy safety class is taught in an FGI suite, unique to each department. A patient equivalent phantom is set on the patient table with an ion chamber positioned at the x-ray beam entrance to the phantom. This provides a surrogatemore » measure of patient entrance dose. Multiple solid state dosimeters (RaySafe i2 dosimetry systemTM) are deployed at different distances from the phantom (0.1, 1, 3 meters), which provide surrogate measures of staff dose. Instructors direct participating clinical staff to operate the fluoroscopy system as they view live fluoroscopic images, patient entrance dose, and staff doses in real-time. During class, instructors work with clinical staff to investigate how patient entrance dose, staff doses, and image quality are affected by different parameters, including pulse rate, magnification, collimation, beam angulation, imaging mode, system geometry, distance, and shielding. Results: Real-time dose visualization enables clinical staff to directly see and learn how to optimize their use of their own fluoroscopy system to minimize patient and staff dose, yet maintain sufficient image quality for FGI. As a direct result of the class, multiple hospital departments have implemented changes to their imaging protocols, including reduction of the default fluoroscopy pulse rate and increased use of collimation and lower dose fluoroscopy modes. Conclusion: Hands-on fluoroscopy safety training substantially benefits from real-time patient and staff dosimetry incorporated into the class. Real-time dose display helps clinical staff visualize, internalize, and ultimately utilize the safety techniques learned during the training. RaySafe/Unfors/Fluke lent us a portable version of their RaySafe i2 Dosimetry System for 6 months.« less
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-16
... completion of a PDP is not filed by the latter of the two dates, and no IDE is in effect, the device is... availability of a preamendments class III devices strategy document. The strategy document set forth FDA's... approved PMA or a declared completed PDP is required to be in effect for any such devices on or before 180...
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2004-03-16
The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
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Embi, Peter J; Acharya, Prasad; McCuistion, Mark; Kishman, Charles P; Haag, Doris; Marine, Stephen
2006-09-06
Information about drug withdrawals may not reach patients in a timely manner, and this could result in adverse events. Increasingly, the public turns to consumer health websites for health information, but such sites may not update their content for days or weeks following important events like Food and Drug Administration (FDA) drug withdrawal actions. There is no recognized standard for how quickly consumer health websites should respond to such events, and reports addressing this issue are lacking. The objective of this study was to develop and implement an approach to enhance the efficiency with which a consumer health website (NetWellness.org) responds to FDA drug withdrawal actions. Evaluation of the current approach used by NetWellness staff to update content affected by FDA action revealed a slow process driven by the goal of performing thorough and comprehensive review and editing. To achieve our desired goal of accurately updating affected content within 24 hours of FDA action, we developed a strategy that included rapid updating of affected Web pages with warning boxes and hyperlinks to the information about the withdrawal. With the next FDA withdrawal event, that of valdecoxib (Bextra) on April 7, 2005, we applied this new approach, observed the time and resource requirements, and monitored the rate at which consumers viewed the updated information to gauge its potential impact. Application of the new approach allowed one person to modify the affected Web pages in less than 1 hour and within 18 hours of the FDA announcement. Using the old strategy, response to a similar event, the withdrawal of rofecoxib (Vioxx) 6 months earlier, had taken over 3 weeks and the efforts of several personnel. Updated valdecoxib content received 188 hits within the first month and 4285 hits within 1 year. Rapid updating of a consumer health website's content in response to an FDA drug withdrawal event was easily accomplished by applying the approach described. This allowed consumers to view accurate information regarding the withdrawn drug much sooner than would otherwise have been the case. Given that consumers increasingly turn to websites for their health information, adoption of a rapid response standard for important health events like FDA drug withdrawals should be considered by the consumer health informatics community.
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Biomedical applications of tissue engineering technology: regulatory issues.
Hellman, K B
1995-01-01
Novel emerging technologies such as tissue engineering, which utilize the approaches of molecular and cell biology, biotechnology, as well as materials science and engineering, are being used in the development of a wide range of biomedical products developed by industries regulated by the U.S. Food and Drug Administration (FDA). The FDA's mission is to promote and protect the public health by ensuring the safety and effectiveness of pharmaceuticals and medical devices, including those manufactured by novel technology, as assessed by scientific principles and methods. Regulatory review is conducted on a product-by-product basis. To accomplish its mission over the wide range of products in its regulatory purview, the FDA has six centers, each staffed with the scientific and regulatory expertise to evaluate the products in the center's jurisdiction. Recent legislative and regulatory changes are designed to simplify and facilitate the administrative process for evaluating novel combination products emanating from such interdisciplinary technology as tissue engineering and to resolve questions of product regulatory jurisdiction. Under the new procedures, the FDA may designate a lead FDA center for product review based on the primary mode of action of the combination product, with additional center(s) designated to assist in the evaluation in a collaborative or consultative capacity. In addition, FDA centers have increased their cooperation and information sharing with regard to evolving interdisciplinary technology. The FDA InterCenter Tissue Engineering Initiative was established to develop information on intercenter efforts in the evaluation of tissue engineering applications and to identify areas for further consideration. The FDA InterCenter Tissue Engineering Working Group, comprised of staff from the Center for Biologies Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Veterinary Medicine (CVM) has developed a Draft Report considering recent developments in tissue engineering and scientific and regulatory issues in the product application areas. The Working Group has identified generic safety and effectiveness issues for consideration by the research and development community in its development of products. The FDA centers are using multiple approaches at their disposal in the evaluation of tissue engineered products including research, data and information monitoring, regulatory guidance, training and education, and cooperation with public and private groups.
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Antiretroviral Drugs Used in the Treatment of HIV Infection
... on April 12, 2018. Multi-class Combination Products Brand Generic Name Pediatric Use Approval Date Time to ... can be found at Drugs@FDA or DailyMed . Brand Name Generic Name Pediatric Use Approval Date Time ...
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Characteristics of FDA drug recalls: A 30-month analysis.
Hall, Kelsey; Stewart, Tyler; Chang, Jongwha; Freeman, Maisha Kelly
2016-02-15
The characteristics of drug recalls issued over 30 months by the Food and Drug Administration (FDA) were analyzed. All FDA-issued recalls for drugs (prescription and nonprescription, including dietary supplements) and biological products issued from June 20, 2012, to December 31, 2014, were included in this retrospective analysis. Data for all drug recalls were downloaded and sorted by the inclusion criteria from weekly FDA enforcement reports. The following data were analyzed: product type, recall firm, type of recall firm (compounding or noncompounding), country, voluntary or involuntary recall, method of communication of recall, recall number, FDA recall classification (class I, II, or III), product availability (prescription or nonprescription), reason for recall, recall initiation date, and recall report date. A total of 21,120 products were recalled during the 30-month study period. Of these, 3,045 drug products (14.4%) met the inclusion criteria and were analyzed. A total of 348 total manufacturers were associated with recalled drug products. The 5 firms most frequently involved in recalls accounted for 299, 273, 212, 118, and 112 recalls. The most common reasons for recalls were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. There was a significant association between FDA recall classification and the following outcomes: reasons for recall, product availability, type of recall firm, and form of communication. An investigation of FDA drug recalls revealed that the five most common recall reasons were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. Compounding firms were associated more frequently with contamination than were noncompounding firms. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.
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Nestle, M
1998-01-01
The Procter & Gamble Company spent 30 years and an estimated $500 million to bring its non-digestible fat substitute, olestra, to market. The Food and Drug Administration approved olestra as a food additive but requires products containing olestra to carry a warning statement about its potential effects on gastrointestinal function. In obtaining approval for olestra, P&G conducted a lengthy, persistent, and comprehensive campaign to enlist support from members of Congress; FDA staff; and food, nutrition, and health professionals. This campaign raises larger questions about corporate influence on government policies, and the relationships of corporations to health professionals. To address these larger concerns, the author reviews the history of olestra's approval; describes P&G's campaign to obtain support from FDA and Congress, to defend olestra against critics, and to market it to professionals, the press, and consumers; and suggests implications for public health policies.
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THPdb: Database of FDA-approved peptide and protein therapeutics.
Usmani, Salman Sadullah; Bedi, Gursimran; Samuel, Jesse S; Singh, Sandeep; Kalra, Sourav; Kumar, Pawan; Ahuja, Anjuman Arora; Sharma, Meenu; Gautam, Ankur; Raghava, Gajendra P S
2017-01-01
THPdb (http://crdd.osdd.net/raghava/thpdb/) is a manually curated repository of Food and Drug Administration (FDA) approved therapeutic peptides and proteins. The information in THPdb has been compiled from 985 research publications, 70 patents and other resources like DrugBank. The current version of the database holds a total of 852 entries, providing comprehensive information on 239 US-FDA approved therapeutic peptides and proteins and their 380 drug variants. The information on each peptide and protein includes their sequences, chemical properties, composition, disease area, mode of activity, physical appearance, category or pharmacological class, pharmacodynamics, route of administration, toxicity, target of activity, etc. In addition, we have annotated the structure of most of the protein and peptides. A number of user-friendly tools have been integrated to facilitate easy browsing and data analysis. To assist scientific community, a web interface and mobile App have also been developed.
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FDA use of international standards in the premarket review process.
Rechen, E; Barth, D J; Marlowe, D; Kroger, L
1998-01-01
"This is an exciting time," says Eric Rechen, policy analyst in the U.S. Food and Drug Administration's (FDA) Office of Device Evaluation (ODE). "We're entering an era in which standards will have a more prominent role in the review of medical devices than ever before." During the past 10 years, there has been significant growth in the importance of standards in regulatory processes, as Donald J. Barth, regulatory staff manager for the Medical Products Group at Hewlett Packard Company, notes in setting the stage for discussion of the latest developments. Donald Marlowe, director of the FDA's Office of Science and Technology, and Rechen explain the use of standards in the regulatory review process as part of FDA efforts to ensure public safety in a time of shrinking agency resources. Marlowe discusses provisions of the FDA Modernization Act of 1997 that allow manufacturers to submit a declaration of conformity to a standard to satisfy premarket review requirements. A guidance on the recognition and use of consensus standards, a list of recognized standards, and a list of frequently asked questions are available at the Web site of the Center for Devices and Radiological Health (CDRH) at www.fda.gov/cdrh and via the AAMI Web site at www.aami.org. The information is also available by telephone via CDRH Facts on Demand at 800-899-0381. Rechen provides details about the two new approaches for premarket notifications available under the new 510(k) paradigm. Manufacturers may demonstrate substantial equivalence through special and abbreviated 510(k)s in addition to traditional 510(k)s. A copy of the new 510(k) paradigm is available at the AAMI and CDRH Web sites and through Facts on Demand. As the FDA and many manufacturers enter the new world of abbreviated and special 510(k)s, Larry Kroger, GE Medical Systems, provides his comments based on the 4 years of experience manufacturers of diagnostic x-ray products have had with simplified 510(k)s. A comparison of the European conformity assessment procedures with the new 510(k) paradigm will appear in an upcoming issue of BI&T.
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ACS chemical neuroscience molecule spotlight on Lorcaserin.
Hopkins, Corey R
2010-11-17
Lorcaserin (APD-356) is the first in a new class of selective serotonin 5-hydroxytryptamine(2C) (5-HT(2C)) receptor agonists. On December 22, 2009, the compound's developer (Arena Pharmaceuticals) submitted an NDA to the FDA for approval for weight management.
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... has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval. Devices that present a low risk of harm to the user (Class I) (for example non-powered breast pumps, elastic bandages, tongue depressors, and ...
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Braithwaite, Gavin J C; Daley, Michael J; Toledo-Velasquez, David
2016-01-01
Hyaluronic acid of various molecular weights has been in use for the treatment of osteoarthritis knee pain for decades. Worldwide, these products are regulated as either as drugs or devices and in some countries as both. In the US, this class of products is regulated as Class III medical devices, which places specific regulatory requirements on developers of these materials under a Pre-Market Approval process, typically requiring data from prospective randomized controlled clinical studies. In 1984 pharmaceutical manufacturers became able to file an Abbreviated New Drug Application for approval of a generic drug, thus establishing standards for demonstrating equivalence to an existing chemical entity. Recently, the first biosimilar, or 'generic biologic', was approved. Biosimilars are biological products that are approved by the FDA because they are 'highly similar' to a reference product, and have been shown to have no clinically meaningful differences from the reference product. For devices, Class II medical devices have a pathway for declaring equivalence to an existing product by filing a 510 k application for FDA clearance. However, until recently no equivalent regulatory pathway was available to Class III devices. In this paper, we consider the critical mechanical performance parameters for intra-articular hyaluronic products to demonstrate indistinguishable characteristics. Analogous to the aforementioned pathways that allow for a demonstration of equivalence, we examine these parameters for an existing, marketed device and compare molecular weight and rheological properties of multiple batches of a similar product. We propose that this establishes a scientific rationale for establishing Class III medical device equivalence.
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Zasowski, Evan; Butterfield, Jill M; McNutt, Louise-Ann; Cohen, Jason; Cosler, Leon; Pai, Manjunath P; Gottwald, Joseph; Chen, Wen Zhen; Lodise, Thomas P
2014-07-01
Recent Food and Drug Administration (FDA) guidance endorses the use of an early clinical response endpoint as the primary outcome for community-acquired bacterial pneumonia (CABP) trials. While antibiotics will now be approved for CABP, in practice they will primarily be used to treat patients with community-acquired pneumonia (CAP). More importantly, it is unclear how achievement of the new FDA CABP early response endpoint translates into clinically applicable real-world outcomes for patients with CAP. To address this, a retrospective cohort study was conducted among adult patients who received ceftriaxone and azithromycin for CAP of Pneumonia Outcomes Research Team (PORT) risk class III and IV at an academic medical center. The clinical response was defined as clinical stability for 24 h with improvement in at least one pneumonia symptom and with no symptom worsening. A classification and regression tree (CART) was used to determine the delay in response time, measured in days, associated with the greatest risk of a prolonged hospital length of stay (LOS) and adverse outcomes (in-hospital mortality or 30-day CAP-related readmission). A total of 250 patients were included. On average, patients were discharged 2 days following the achievement of a clinical response. In the CART analysis, adverse clinical outcomes were higher among day 5 nonresponders than those who responded by day 5 (22.4% versus 6.9%, P = 0.001). The findings from this study indicate that time to clinical response, as defined by the recent FDA guidance, is a reasonable prognostic indicator of real-world effectiveness outcomes among hospitalized PORT risk class III and IV patients with CAP who received ceftriaxone and azithromycin. Copyright © 2014, American Society for Microbiology. All Rights Reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-05
... European Protocol for the Quality Control of the Physical and Technical Aspects of Mammography Screening... entitled ``Physical Laboratory Testing, Breast Compression System'' to follow the Mammography Quality...] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...
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Code of Federal Regulations, 2011 CFR
2011-04-01
.... (d) Master file means a reference source that a person submits to FDA. A master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the... for a class III medical device, including all information submitted with or incorporated by reference...
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21 CFR 870.3450 - Vascular graft prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...
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21 CFR 870.3450 - Vascular graft prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...
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21 CFR 870.3450 - Vascular graft prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...
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21 CFR 870.3450 - Vascular graft prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...
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ACS Chemical Neuroscience Molecule Spotlight on Lorcaserin
2010-01-01
Lorcaserin (APD-356) is the first in a new class of selective serotonin 5-hydroxytryptamine2C (5-HT2C) receptor agonists. On December 22, 2009, the compound's developer (Arena Pharmaceuticals) submitted an NDA to the FDA for approval for weight management. PMID:22778808
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Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA
Abels, Esther; Pantanowitz, Liron
2017-01-01
The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a de novo. This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use. PMID:28584684
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Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA.
Abels, Esther; Pantanowitz, Liron
2017-01-01
The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a de novo . This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use.
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ERIC Educational Resources Information Center
Sleeter, Christine E.
1992-01-01
A study of predominantly white teachers participating in a multicultural education staff development program illustrated how social class and gender experiences informed their understanding of the social order they used to understand race. Following the staff development, few teachers substantially restructured their perspectives about racial…
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K-3 Support: Blending Teaching, Counseling, and Social Services.
ERIC Educational Resources Information Center
Derrington, Mary Lynne; Mendonsa, Cathie
1992-01-01
To meet student needs, the Port Angeles School District (Washington) K-3 Support Program has certified staff that serve as a blend of social service providers, counselors, and teachers. They provide in-class lessons, staff consultation, direct student services, and parenting classes. Appended is a list of eight additional resources. (MLF)
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The Value of Childcare: Class, Gender and Caring Labour
ERIC Educational Resources Information Center
Andrew, Yarrow; Newman, Brian
2012-01-01
Despite increasing attention being paid to early childhood services as the foundation for lifelong learning, one issue seems to be consistently ignored--staff wages. The authors argue that this constitutes ongoing exploitation of childcare staff, and that this exploitation is a result of gendered and classed discourses around caring labour. As…
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Fagan, Pebbles; Pokhrel, Pallav; Herzog, Thaddeus A; Guy, Mignonne C; Sakuma, Kari-Lyn K; Trinidad, Dennis R; Cassel, Kevin; Jorgensen, Dorothy; Lynch, Tania; Felicitas-Perkins, Jamie Q; Palafox, Sherilyn; Hamamura, Faith; Maloney, Sarah; Degree, Kaylah; Sterling, Kymberle; Moolchan, Eric; Clanton, Mark S; Eissenberg, Thomas
2017-05-18
Prior to the Food and Drug Administration's (FDA) regulation of electronic cigarettes and warning statements related to nicotine addiction, there was no critical examination of manufacturer/distributor voluntary practices that could potentially inform FDA actions aimed to protect consumers. This study examined the content of warning statements and safety characteristics of electronic cigarette liquid bottles using a national sample. Research staff randomly selected four electronic cigarette liquid manufacturers/distributors from four U.S. geographic regions. Staff documented the characteristics of product packaging and content of warning statements on 147 electronic cigarette liquids (0-30 mg/ml of nicotine) purchased online from 16 manufacturers/distributors in April of 2016. Data showed that 97.9% of the electronic cigarette liquid bottles included a warning statement, most of which focused on nicotine exposure rather than health. Only 22.4% of bottles used a warning statement that indicated the product "contained nicotine". Of bottles that advertised a nicotine-based concentration of 12 mg/ml, 26% had a warning statements stated that the product "contains nicotine". None of the statements that indicated that the product "contained nicotine" stated that nicotine was "addictive". All bottles had a safety cap and 12% were in plastic shrink-wrap. Fifty-six percent of the websites had a minimum age requirement barrier that prevented under-aged persons from entering. Most manufacturers/distributors printed a warning statement on electronic cigarette liquid bottles, but avoided warning consumers about the presence and the addictiveness of nicotine. Studies are needed to examine manufacturer/distributor modifications to product packaging and how packaging affects consumer behaviors. These data can inform future FDA requirements related to the packaging and advertising of e-cigarette liquids; regulation related to the content of warning statements, including exposure warning statements, which are not currently mandated; and requirements on websites or language on packaging to help manufacturers adhere to the minimum age of purchase regulation. The data can also be used to help FDA develop additional guidance on the framing of statements on packaging that helps consumers make informed decisions about purchasing the product or protecting young people from use or unintentional exposure to the product. © The Author 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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... The percentage of states that provided funding for staff development or offered staff development on injury prevention and safety to those ... classes or courses with a teacher who received staff development on injury prevention and safety increased from ...
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78 FR 2647 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-14
.... FDA-2012-N-0677] Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant AGENCY: Food...) is proposing to reclassify the blade- form endosseous dental implant, a preamendments class III... proposing to revise the classification of blade-form endosseous dental implants. DATES: Submit either...
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An Analysis of “Natural” Food Litigation to Build a Sesame Allergy Consumer Class Action.
Shaker, Dana
In a world where food allergy is still an incurable disease, law and regulation stand as necessary mechanisms to provide food-allergic consumers with the information they need to protect their health. The Food Allergen Labeling and Consumer Protection Act of 2004 provided specific labeling requirements for the “Top Eight” allergens in the U.S.: milk, soy, gluten, egg, tree nut, peanut, fish, and Crustacean shellfish. Since then, sesame has become more prevalent as an allergen and remains just as dangerous, inducing anaphylactic shock in some sesame-allergic individuals. Yet sesame remains unregulated, despite advocates and congressional members arguing for its inclusion. This note entertains one solution to this problem by exploring the most strategic way to bring a sesame allergy class action against a private food company under California’s consumer protection statutes. Because this kind of class action does not have much, if any, precedent, this note analyzes the basic, preliminary issues that any litigant would have to navigate around to certify a class, including preemption, standing, and the claim itself, by focusing on how courts have examined these issues in the recent “natural” class action litigation. It also analyzes the legal, moral, and practical aspects of choosing a type of relief, as well as whom to include in the class. Finally, this note briefly considers how FDA itself can ensure sesame is regulated on the labels of food products, given that some of the legal issues may well be insurmountable for this particular class action. This note explores the potential solutions to difficult legal hurdles in constructing a sesame allergy class action, arguing that litigating a sesame allergy class action—even if it is not ultimately successful—could start a productive conversation that might lead Congress or FDA to provide greater public health and consumer protection for those with sesame allergy.
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Outreach to Scientists and Engineers at the Hanford Technical Library
DOE Office of Scientific and Technical Information (OSTI.GOV)
Buxton, Karen A.
Staff at the Hanford Technical Library has developed a suite of programs designed to help busy researchers at the Pacific Northwest National Laboratory (PNNL) make better use of library products and services. Programs include formal training classes, one-on-one consultations, and targeted email messages announcing new materials to researchers in specific fields. A staple of outreach has been to teach classes to library clients covering research tools in their fields. These classes started out in the library classroom and then expanded to other venues around PNNL. Class surveys indicated that many researchers desired a practical approach to learning rather than themore » traditional lecture format. The library instituted “Library Learning Day” and hosted classes in the PNNL computer training room to provide lab employees with a hands-on learning experience. Classes are generally offered at noon and lab staff attends classes on their lunch hour. Many just do not have time to spend a full hour in training. Library staff added some experimental half-hour mini classes in campus buildings geared to the projects and interests of researchers there to see if this format was more appealing. As other programs have developed librarians are teaching fewer classes but average attendance figures has remained fairly stable from 2005-2007. In summer of 2004 the library began the Traveling Librarian program. Librarians call-on groups and individuals in 24 buildings on the Richland Washington campus. Five full-time and two part-time librarians are involved in the program. Librarians usually send out email announcements prior to visits and encourage scientists and engineers to make appointments for a brief 15 minute consultation in the researcher’s own office. During the meeting lab staff learn about products or product features that can help them work more productively. Librarians also make cold calls to staff that do not request a consultation and may not be making full use of the library. Scientists and engineers who require longer sessions can arrange half-hour training appointments in the researcher’s own office or at the library. Since the program was implemented staff made 165 visits to 1249 laboratory staff including some repeat consultation requests. New acquisitions lists are sent to individuals and groups that would be interested in recent journal, database, and books purchases. These lists are topic specific and targeted to groups and individuals with an interest in the field. For example newly acquired engineering resources are targeted at engineering groups. The new acquisitions list for engineering began mid year in 2005. An analysis of circulation statistics for engineering books in fiscal year 2005, 2006, and 2007 show that circulation increased each year with 2007 circulation nearly double that of 2005. This took place when overall circulation rose in FY06 but fell slightly in FY07. Outreach strategies tailored and individualized can be effective. Offering multiple outreach options offers researchers different ways to interact with library staff and services.« less
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ERIC Educational Resources Information Center
Oldfield, Kenneth
2007-01-01
American universities are seeking to increase "academic staff diversity" by hiring more females, racial/ethnic minorities, military veterans, and persons with disabilities. Various researchers have presented evidence showing that people of poverty and working-class origins are significantly underrepresented within the US academic staff.…
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ERIC Educational Resources Information Center
Baldus, Lorayne
A staff development program on gender equity was conducted for personnel in Wisconsin's technical colleges using the train-the-trainer method. The training took two approaches: a class for college personnel and career challenge training for project directors of single parent and displaced homemaker grants. The inservice class resulted in increased…
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2016-07-13
The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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21 CFR 814.19 - Product development protocol (PDP).
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA under...
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21 CFR 814.19 - Product development protocol (PDP).
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA under...
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21 CFR 884.5970 - Clitoral engorgement device.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Clitoral engorgement device. 884.5970 Section 884.5970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-28
... [Docket No. FDA-2009-N-0493] RIN 0910-ZA37 Neurological and Physical Medicine Devices; Designation of... document proposed to amend certain neurological and physical medicine device regulations to establish... to amend certain neurological device and physical medicine device regulations to establish special...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-17
... for Preventing Cross- Contamination; Availability AGENCY: Food and Drug Administration, HHS. ACTION... require separation of manufacturing facilities to avoid cross-contamination, the only class of products... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104...
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Tazawa, Yoshiaki
2016-01-01
On July 1st, 2013, the Ministry of Health, Labor and Welfare (MHLW) issued an official notification regarding the co-development of companion diagnostics (CDx) with a drug which requires any exclusive diagnostic test or medical device to predict efficacy or adverse reactions to the drug. The main frame and contents in the MHLW's notification are quite similar to the summaries in the final guidance issued by the US Food and Drug Administration (FDA) on August 6th, 2014 Guidance for Industry and Food and Drug Administration Staff (In Vitro Companion Diagnostic Devices, [2014] ), and these recommend industries to develop, study and submit CDx and the corresponding drug contemporaneously as much as possible. Following the MHLW's notification, the Pharmaceutical and Medical Device Agency (PMDA) notified on December 26th, 2013, "the technical guidance for co-development of CDx and the drug" that mentioned the regulatory requirements for clinical trial of the drug and CDx as well as analytical validity of CDx required for the trials. These official notifications from the Ministry and the Agency may be useful for pharmaceutical and diagnostics makers to understand how they should co-develop and validate CDx for clinical trials and regulatory submission. However, since the most anticipated technologies such as the next generation sequencer (NGS) are more complex and its medical risks could be high level, the existing regulatory system focusing on only diagnostics reagents and devices that are developed and manufactured by in vitro diagnostics (IVD) makers may be no longer suitable for the characteristics of CDx for the future.As an increase of clinical needs for multiple biomarkers assay by DNA sequencer, on November 19th, 2013, the FDA cleared 510 K for NGS and its universal kit. On October 3rd, 2014, moreover, the agency notified two drafts of guidance (Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), [2014]; Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDT), [2014]) for oversight of laboratory developed tests (LDTs) with medium or high medical risks. These FDA's strategic decisions and new regulatory frameworks may allow the clinical laboratories to develop and perform more easily NGS-based CDx under the certification of Clinical Laboratory Improvement Amendments (CLIA). However, neither law nor regulated quality management system similar to the CLIA exists in Japan. To effectively validate LDTs and NGS for medical practice, Japan should learn more the current regulatory changes and initiatives in the US, as well as to reform the regulatory frameworks and create any regulated quality management system for clinical laboratory testing to be reimbursed.
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Integration of new technology into clinical practice after FDA approval.
Govil, Ashul; Hao, Steven C
2016-10-01
Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.
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A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves.
Yoganathan, Ajit P; Fogel, Mark; Gamble, Susan; Morton, Michael; Schmidt, Paul; Secunda, Jeff; Vidmar, Sara; Del Nido, Pedro
2013-10-01
Congenital heart valve disease is one of the most common abnormalities in children. There are limited technological solutions available for treating children with congenital heart valve diseases. The aim of this study is to provide the details of the consensus reached in terms of pediatric definitions, design approach, in vitro testing, and clinical trials, which may be used as guidance for developing prosthetic heart valves for the pediatric indication. In stark contrast to the various designs of adult-sized replacement valves available in the market, there are no Food and Drug Administration (FDA)-approved prosthetic heart valves available for use in the pediatric population. There is a pressing need for FDA-approved pediatric valve devices in the United States. The pediatric patient population has been typically excluded from replacement heart valve trials for several reasons. In January 2010, heart valve manufacturers and pediatric clinicians collaborated with academicians and FDA staff in a workshop to suggest ways to successfully evaluate pediatric prosthetic valves and conduct pediatric clinical trials to provide acceptable heart valve replacement options for this patient population. Recommendations, derived from ISO 5840:2005 and the 2010 FDA Draft Replacement Heart Valve Guidance, are provided for hydrodynamic, durability, and fatigue testing. The article specifically addresses in vitro and premarket and postmarket approval clinical studies that should be considered by a heart valve manufacturer for obtaining regulatory approval of pediatric sizes of prosthetic heart valve designs that are already approved for adult clinical use. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.
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Smith, Jeffrey K
2013-04-01
Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such systems are used within FDA to manage information and processes surrounding the processing, review, and tracking of investigational and marketed product submissions. This is an area of increasing interest in the pharmaceutical industry and has been a topic at trade association conferences (Buckley 2012). Such databases in CBER are complex, not for the type or relevance of the data to any particular scientific discipline but because of the variety of regulatory submission types and processes the systems support using the data. Commonalities among different data domains of CBER's regulatory administrative databases are discussed. These commonalities have evolved enough to constitute real database convergence and provide a valuable asset for business process intelligence. Balancing review workload across staff, exploring areas of risk in review capacity, process improvement, and presenting a clear and comprehensive landscape of review obligations are just some of the opportunities of such intelligence. This convergence has been occurring in the presence of usual forces that tend to drive information technology (IT) systems development toward separate stovepipes and data silos. CBER has achieved a significant level of convergence through a gradual process, using a clear goal, agreed upon development practices, and transparency of database objects, rather than through a single, discrete project or IT vendor solution. This approach offers a path forward for FDA systems toward a unified database.
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34 CFR 364.24 - What assurances are required for staff development?
Code of Federal Regulations, 2011 CFR
2011-07-01
... 34 Education 2 2011-07-01 2010-07-01 true What assurances are required for staff development? 364... Requirements? § 364.24 What assurances are required for staff development? The State plan must assure that the service provider establishes and maintains a program of staff development for all classes of positions...
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34 CFR 364.24 - What assurances are required for staff development?
Code of Federal Regulations, 2010 CFR
2010-07-01
... 34 Education 2 2010-07-01 2010-07-01 false What assurances are required for staff development? 364... Requirements? § 364.24 What assurances are required for staff development? The State plan must assure that the service provider establishes and maintains a program of staff development for all classes of positions...
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Economics of new oncology drug development.
DiMasi, Joseph A; Grabowski, Henry G
2007-01-10
Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.
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Gong, Jun; Chehrazi-Raffle, Alexander; Reddi, Srikanth; Salgia, Ravi
2018-01-23
Early preclinical evidence provided the rationale for programmed cell death 1 (PD-1) and programmed death ligand 1 (PD-L1) blockade as a potential form of cancer immunotherapy given that activation of the PD-1/PD-L1 axis putatively served as a mechanism for tumor evasion of host tumor antigen-specific T-cell immunity. Early-phase studies investigating several humanized monoclonal IgG4 antibodies targeting PD-1 and PD-L1 in advanced solid tumors paved way for the development of the first PD-1 inhibitors, nivolumab and pembrolizumab, approved by the Food and Drug Administration (FDA) in 2014. The number of FDA-approved agents of this class is rapidly enlarging with indications for treatment spanning across a spectrum of malignancies. The purpose of this review is to highlight the clinical development of PD-1 and PD-L1 inhibitors in cancer therapy to date. In particular, we focus on detailing the registration trials that have led to FDA-approved indications of anti-PD-1 and anti-PD-L1 therapies in cancer. As the number of PD-1/PD-L1 inhibitors continues to grow, predictive biomarkers, mechanisms of resistance, hyperprogressors, treatment duration and treatment beyond progression, immune-related toxicities, and clinical trial design are key concepts in need of further consideration to optimize the anticancer potential of this class of immunotherapy.
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Surana, Sikander; Kumar, Neeru; Vasudeva, Amita; Shaikh, Gulvahid; Jhaveri, Kenar D; Shah, Hitesh; Malieckal, Deepa; Fogel, Joshua; Sidhu, Gurwinder; Rubinstein, Sofia
2017-01-17
Drug dosing errors result in adverse patient outcomes and are more common in patients with chronic kidney disease (CKD). As internists treat the majority of patients with CKD, we study if Internal Medicine house-staff have awareness and knowledge about the correct dosage of commonly used medications for those with CKD. A cross-sectional survey was performed and included 341 participants. The outcomes were the awareness of whether a medication needs dose adjustment in patients with CKD and whether there was knowledge for the level of glomerular filtration rate (GFR) a medication needs to be adjusted. The overall pattern for all post-graduate year (PGY) groups in all medication classes was a lack of awareness and knowledge. For awareness, there were statistically significant increased mean differences for PGY2 and PGY3 as compared to PGY1 for allergy, endocrine, gastrointestinal, and rheumatologic medication classes but not for analgesic, cardiovascular, and neuropsychotropic medication classes. For knowledge, there were statistically significant increased mean differences for PGY2 and PGY3 as compared to PGY1 for allergy, cardiovascular, endocrine, and gastrointestinal, medication classes but not for analgesic, neuropsychotropic, and rheumatologic medication classes. Internal Medicine house-staff across all levels of training demonstrated poor awareness and knowledge for many medication classes in CKD patients. Internal Medicine house-staff should receive more nephrology exposure and formal didactic educational training during residency to better manage complex treatment regimens and prevent medication dosing errors.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-11
.... FDA-2008-N-0163] (formerly Docket No. 2001N-0067) RIN 0910-AG21 Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam... the Federal Register of August 4, 2009 (74 FR 38686) which classified dental amalgam as a class II...
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78 FR 79299 - New Animal Drugs for Use in Animal Feeds; Bambermycins; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2013-N-0002] New Animal Drugs for Use in Animal Feeds; Bambermycins; Correction AGENCY: Food and... amended the animal drug regulations to remove dairy replacement heifers from the pasture cattle class for...
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21 CFR 878.4493 - Absorbable poly(glycolide/l-lactide) surgical suture.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Absorbable poly(glycolide/l-lactide) surgical suture. 878.4493 Section 878.4493 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and...
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Nestle, M
1998-01-01
The Procter & Gamble Company spent 30 years and an estimated $500 million to bring its non-digestible fat substitute, olestra, to market. The Food and Drug Administration approved olestra as a food additive but requires products containing olestra to carry a warning statement about its potential effects on gastrointestinal function. In obtaining approval for olestra, P&G conducted a lengthy, persistent, and comprehensive campaign to enlist support from members of Congress; FDA staff; and food, nutrition, and health professionals. This campaign raises larger questions about corporate influence on government policies, and the relationships of corporations to health professionals. To address these larger concerns, the author reviews the history of olestra's approval; describes P&G's campaign to obtain support from FDA and Congress, to defend olestra against critics, and to market it to professionals, the press, and consumers; and suggests implications for public health policies. Images p508-a p509-a p510-a p511-a p512-a p513-a p515-a p516-a p517-a PMID:9847922
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García-Arieta, Alfredo
2014-12-18
The aim of the present paper is to illustrate the impact that excipients may have on the bioavailability of drugs and to review existing US-FDA, WHO and EMA regulatory guidelines on this topic. The first examples illustrate that small amounts of sorbitol (7, 50 or 60mg) affect the bioavailability of risperidone, a class I drug, oral solution, in contrast to what is stated in the US-FDA guidance. Another example suggests, in contrast to what is stated in the US-FDA BCS biowaivers guideline, that a small amount of sodium lauryl sulphate (SLS) (3.64mg) affects the bioavailability of risperidone tablets, although the reference product also includes SLS in an amount within the normal range for that type of dosage form. These factors are considered sufficient to ensure that excipients do not affect bioavailability according to the WHO guideline. The alternative criterion, defined in the WHO guideline and used in the FIP BCS biowaivers monographs, that asserts that excipients present in generic products of the ICH countries do not affect bioavailability if used in normal amounts, is shown to be incorrect with an example of alendronate (a class III drug) tablets, where 4mg of SLS increases bioavailability more than 5-fold, although a generic product in the USA contains SLS. Finally, another example illustrates that a 2mg difference in SLS may affect bioavailability of a generic product of a class II drug, even if SLS is contained in the comparator product, and in all cases its amount was within the normal range. Therefore, waivers of in vivo bioequivalence studies (e.g., BCS biowaivers, waivers of certain dosage forms in solution at the time of administration and variations in the excipient composition) should be assessed more cautiously. Copyright © 2014 Elsevier B.V. All rights reserved.
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Joint Chiefs of Staff > Directorates > J6 | C4 & Cyber
the Joint Staff Chief Information Officer (CIO), the J-6 provides business class Information on Facebook on Flickr Joint Chiefs⺠Army Chief of Staff Marine Corps Commandant Chief of Naval Operations Air Force Chief of Staff Chief of National Guard Bureau Biographies Directorates Directorates of
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2014-10-22
The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
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2015-11-20
The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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2017-07-27
The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
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Thomas, Rachel Hutchins; Freeman, Maisha Kelly; Hughes, Peter J
2013-07-15
Preapproval and postapproval availability of published comparative efficacy studies on biological agents approved between 2000 and 2010 was investigated. Approval packages published on the Food and Drug Administration (FDA) website were examined for all biological agents approved between 2000 and 2010 to determine if comparative efficacy studies were available at the time of FDA approval. The availability of comparative efficacy studies published subsequent to approval was determined by searching PubMed for randomized, active-controlled experimental or observational study designs that measured efficacy as the primary endpoint and were relevant to the original FDA-approved indication. From 2000 to 2010, 107 biological agents were approved by FDA. Of the biological agents with alternative treatments, 54.6% had comparative efficacy data available at the time of approval. Although standard-reviewed biological agents were more likely to have comparative efficacy trials included in the FDA approval packages than priority-reviewed biological agents, statistically significant differences are unlikely. Subsequent to approval, 58.1% of biological agents had at least one published comparative efficacy trial, representing a 3.5% absolute increase in the availability of comparative efficacy studies since the time of approval. Vaccines and biological agents in the hematologic diseases, oncology, and miscellaneous diseases classes had fewer published postapproval comparative efficacy studies per agent compared with the overall group of biological agents. Nearly half of all biological agents approved for marketing between 2000 and 2010 lacked publicly accessible, active-controlled efficacy studies at the time of drug approval; a slightly greater proportion of biological agents had comparative efficacy data published subsequent to their approval.
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The safety and regulation of natural products used as foods and food ingredients.
Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J
2011-10-01
The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.
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Case studies with new excipients: development, implementation and regulatory approval.
Koo, Otilia M Y; Varia, Sailesh A
2011-07-01
The purpose of this article is to describe the process whereby new excipients become accepted and to describe three case studies to illustrate the process. New excipients are defined according to the 2005 FDA Guidance on Nonclinical Safety Evaluation of New Excipients. The requirements for safety data submission for new excipients used in different classes of products for different durations are outlined in the guidance. Currently, the development of new excipients is linked to the development and approval of new drug products that contain them. New excipients that are used in US-approved drug products become listed in the FDA Inactive Ingredients Guide (IIG) database. Thereafter, US Pharmacopeia monographs for the new excipients are proposed. New excipients are reviewed and become accepted in the same way in Europe and Japan, except that there is no equivalent IIG database. Therefore, the focus of this article will be on the FDA review process. Three case studies, polyoxyl 15 hydroxystearate, sulfobutyl ether cyclodextrin and silicified microcrystalline cellulose, are used to illustrate how new excipients are accepted and implemented.
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Lin, Hui-Heng; Zhang, Le-Le; Yan, Ru; Lu, Jin-Jian; Hu, Yuanjia
2017-09-25
The U.S. Food and Drug Administration (FDA) approves new drugs every year. Drug targets are some of the most important interactive molecules for drugs, as they have a significant impact on the therapeutic effects of drugs. In this work, we thoroughly analyzed the data of small molecule drugs approved by the U.S. FDA between 2000 and 2015. Specifically, we focused on seven classes of new molecular entity (NME) classified by the anatomic therapeutic chemical (ATC) classification system. They were NMEs and their corresponding targets for the cardiovascular system, respiratory system, nerve system, general anti-infective systemic, genito-urinary system and sex hormones, alimentary tract and metabolisms, and antineoplastic and immunomodulating agents. To study the drug-target interaction on the systems level, we employed network topological analysis and multipartite network projections. As a result, the drug-target relations of different kinds of drugs were comprehensively characterized and global pictures of drug-target, drug-drug, and target-target interactions were visualized and analyzed from the perspective of network models.
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de Claro, R Angelo; McGinn, Karen M; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E; Chang, C J George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao Robert; Al-Hakim, Ali; Kane, Robert C; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T; Pazdur, Richard
2015-08-15
On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea. ©2015 American Association for Cancer Research.
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Food and Drug Administration Regulation of Diabetes-Related mHealth Technologies
Brooke, M. Jason; Thompson, Bradley Merrill
2013-01-01
mHealth smartphone applications (apps) offer great promise for managing people with diabetes, as well as those with prediabetes. But to realize that potential, industry needs to get clarity from the U.S. Food and Drug Administration (FDA) regarding the scope of its regulatory oversight. Certain smartphone apps, when properly understood, simply help people live healthier lives, assisting with dietary choices, monitoring exercise, and recording other factors important to overall health. The manufacturers of such apps, in an effort to promote their products but also to educate customers, might wish to explain how using the app can help reduce the risk of developing diabetes. Right now, though, the mere mention of the disease “diabetes” would cause the app to be regulated by the FDA. Such regulation, we submit, discourages the kind of education and motivational messages that our country needs to stem the tide of this disease. Further, should the app simply receive data from a blood glucose meter and graph that data for easier comprehension by the patient, the app would become a class II medical device that requires FDA clearance. Again, we submit that such simple software functionality should not be so discouraged. In this article, we identify the issues that we believe need to be clarified by the FDA in order to unleash the potential of mHealth technology in the diabetes space. PMID:23566984
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New Antiretroviral Therapies for Pediatric HIV Infection
Morris, Jennifer L.; Kraus, Donna M.
2005-01-01
Human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome affect millions of children worldwide. The development of antiretroviral therapy has significantly improved the morbidity and mortality of pediatric patients infected with HIV. Currently, 4 classes of antiretroviral agents exist: nucleoside / nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, and entry inhibitors. A total of 21 single-entity antiretroviral agents and 4 co-formulated antiretroviral products hold Food and Drug Administration (FDA) approval for treatment of HIV-1 infection. However, not all of these agents are indicated for use in patients less than 18 years of age. Since the year 2000, 7 new antiretroviral agents (atazanavir, emtricitabine, enfuvirtide, fosamprenavir, lopinavir/ritonavir, tenofovir, and tipranavir) have been approved by the FDA for use in adult patients as part of combination therapy for the treatment of HIV-1 infection. Although only 3 of these newer agents (emtricitabine, enfuvirtide, and lopinavir/ritonavir) are currently FDA approved for use in pediatric patients, pediatric clinical studies of the other 4 new agents are currently underway. The purpose of this article is to review these 7 new antiretroviral agents and describe their roles in the treatment of pediatric HIV infection. For each drug, the following information will be addressed: FDA-approved indication and age groups, clinical efficacy, pharmacokinetics, adverse drug reactions, clinically relevant drug interactions, pediatric and adult dosing, dosage forms, administration, and place in the treatment of pediatric HIV infection. PMID:23118639
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2005 Donor Eligibility Requirements: Unintended Consequences for Stem Cell Development.
Couture, Larry A; Carpenter, Melissa K
2015-10-01
Several human embryonic stem cell (hESC)-derived cell therapeutics have entered clinical testing and more are in various stages of preclinical development. The U.S. Food and Drug Administration (FDA) regulates these products under existing regulations and has stated that these products do not constitute a new class of biologic. However, as human tissue, hESCs are subject to regulations that were developed before hESCs were first described. The regulations have not been revised since 2005, well before the first hESC-derived product entered clinical studies. The current regulations require donors of hESCs to be tested in the same manner as donors of tissues intended for transplantation. However, because hESC-derived cell products are more than minimally manipulated, they are also subject to the same end-of-production release testing as most other biologic agents. In effect, this makes hESC products subject to redundant testing. No other biologic is subject to a similar testing requirement. Furthermore, the regulations that require donor testing are specifically applicable to hESC cells harvested from donors after a date in 2005. It is unclear which regulations cover hESCs harvested before 2005. Ambiguity in the guidelines and redundant testing requirements have unintentionally created a burdensome regulatory paradigm for these products and reluctance on the part of developers to invest in these promising therapeutics. We propose a simple solution that would address FDA safety concerns, eliminate regulatory uncertainty and risk, and provide flexibility for the FDA in the regulation of hESC-derived cell therapies. Regulatory ambiguity concerning donor eligibility screening and testing requirements for human embryonic stem cell lines, in particular those lines created before 2005, are causing significant concern for drug developers. Technically, most of these lines fail to meet eligibility under U.S. Food and Drug Administration (FDA) rules for product licensure, and many developers are unaware that FDA approval to begin trials under an exemption is not an assurance that the FDA will grant licensure of the product. This Perspective outlines the ambiguity and the problem it has caused and proposes a workable solution. The intent is to generate stakeholder and FDA discussion on this issue. ©AlphaMed Press.
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Gopal, Anand D; Rathi, Vinay K; Teng, Christopher C; Del Priore, Lucian; Ross, Joseph S
2017-08-01
To characterize the frequency, nature, and regulatory mechanisms by which ophthalmic devices are iteratively modified after initial Food and Drug Administration (FDA) Premarket Approval (PMA). Retrospective cross-sectional analysis using publicly available FDA data. Ophthalmic devices initially approved via the FDA's PMA pathway between January 1, 1979 and December 31, 2015. We used the FDA's PMA Database to identify and characterize initial approvals and subsequent postmarket modifications to Class III ophthalmic devices. The FDA Recalls Database was used to identify associated safety events. Median iterated life span (timespan across which modifications occurred after initial PMA) and median number of supplements approved per device, by device type, and overall, stratified by regulatory pathway and modification type. Between 1979 and 2015, the FDA approved 168 original ophthalmic devices via the PMA pathway and 2813 subsequent modifications. More than one third (n = 64; 38%) of original approvals were intraocular lenses. Overall, devices underwent a median of 11 postmarket modifications (interquartile range [IQR], 3-24.8) across a median 10.0-year iterated life span (IQR, 4.1-16.7). The majority of devices (n = 144; 86%) underwent more than 1 postapproval modification, including more than 1 design modification (n = 84; 50%). The median number of changes altering device design or labeling was 3.5 (IQR, 1-9). Although manufacturing alterations (n = 834 of 2813; 30%) were the most frequent type of revision, changes involving device design (n = 667; 24%) and labeling (n = 417; 15%) were common. Recalled devices underwent more frequent postapproval modifications per year (median, 1.4; IQR, 0.7-2.3; mean, 1.5; 95% confidence interval, 1.1-1.9) in the period preceding recall than did nonrecalled devices (median, 0.5; IQR, 0.2-1.1; mean, 0.8; 95% confidence interval, 0.7-1.0) across their market approval period (P < 0.001). Most ophthalmic devices approved via the FDA's PMA pathway have undergone extensive revisions, including serial design and labeling changes, since their initial approvals, often without supporting clinical data. Ophthalmologists should take into consideration that cumulative revisions may render the clinical evidence that supported an original FDA approval less relevant to newer device models. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Berkeley Lab - Materials Sciences Division
Investigators Division Staff Facilities and Centers Staff Jobs Safety Personnel Resources Committees In Case of ? Click Here! Commitment to Safety at MSD In the Materials Sciences Division, our mission is to do world -class science in a safe environment. We proudly support a strong safety culture in which all staff and
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Wang, Haipeng; Tang, Chengxiang; Zhao, Shichao; Meng, Qingyue; Liu, Xiaoyun
2017-01-01
Background: The lower job satisfaction of health-care staff will lead to more brain drain, worse work performance, and poorer health-care outcomes. The aim of this study was to identify patterns of job satisfaction among health-care staff in rural China, and to investigate the association between the latent clusters and health-care staff’s personal and professional features; Methods: We selected 12 items of five-point Likert scale questions to measure job satisfaction. A latent-class analysis was performed to identify subgroups based on the items of job satisfaction; Results: Four latent classes of job satisfaction were identified: 8.9% had high job satisfaction, belonging to “satisfied class”; 38.2% had low job satisfaction, named as “unsatisfied class”; 30.5% were categorized into “unsatisfied class with the exception of interpersonal relationships”; 22.4% were identified as “pseudo-satisfied class”, only satisfied with management-oriented items. Low job satisfaction was associated with specialty, training opportunity, and income inequality. Conclusions: The minority of health-care staff belong to the “satisfied class”. Three among four subgroups are not satisfied with income, benefit, training, and career development. Targeting policy interventions should be implemented to improve the items of job satisfaction based on the patterns and health-care staff’s features. PMID:28937609
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Middle Class Dropouts: Myths and Observations.
ERIC Educational Resources Information Center
Balfour, Mary J.; Harris, Linda Hall
1979-01-01
Observations about middle class high school dropouts are reported by staff of Project SAIL (Student Advocates Inspire Learning), an intensive special program involving peer and individual counseling. (CL)
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Cutaneous Adverse Effects of Neurologic Medications.
Bahrani, Eman; Nunneley, Chloe E; Hsu, Sylvia; Kass, Joseph S
2016-03-01
Life-threatening and benign drug reactions occur frequently in the skin, affecting 8 % of the general population and 2-3 % of all hospitalized patients, emphasizing the need for physicians to effectively recognize and manage patients with drug-induced eruptions. Neurologic medications represent a vast array of drug classes with cutaneous side effects. Approximately 7 % of the United States (US) adult population is affected by adult-onset neurological disorders, reflecting a large number of patients on neurologic drug therapies. This review elucidates the cutaneous reactions associated with medications approved by the US Food and Drug Administration (FDA) to treat the following neurologic pathologies: Alzheimer disease, amyotrophic lateral sclerosis, epilepsy, Huntington disease, migraine, multiple sclerosis, Parkinson disease, and pseudobulbar affect. A search of the literature was performed using the specific FDA-approved drug or drug classes in combination with the terms 'dermatologic,' 'cutaneous,' 'skin,' or 'rash.' Both PubMed and the Cochrane Database of Systematic Reviews were utilized, with side effects ranging from those cited in randomized controlled trials to case reports. It behooves neurologists, dermatologists, and primary care physicians to be aware of the recorded cutaneous adverse reactions and their severity for proper management and potential need to withdraw the offending medication.
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The World Bank Rural Development Field Staff Distance Learning and Training Strategy.
ERIC Educational Resources Information Center
Mortera-Gutierrez, Fernando
The Rural Development Distance Learning and Training Strategy targets locally recruited field staff of the World Bank Rural Sector. Field staff at the bank's mission offices worldwide are heterogeneous in terms of culture, ethnicity, race, gender, social class, and religion. However, they have the following in common: they follow the Bank's work…
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ERIC Educational Resources Information Center
Byers, Philippa; Tni, Massimiliano
2014-01-01
This paper examines the effectiveness of a programme of weekly meetings between sessional staff and the unit coordinator of a large first-year class at an Australian university. Interviews with sessional staff indicate that, in addition to training and targeted professional development initiatives, management initiatives that promote engagement…
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Give Your Technology Program a Little "Class"!
ERIC Educational Resources Information Center
Vengersammy, Ormilla
2009-01-01
The Orange County Library System (OCLS) began to offer basic technology classes in July 2000. The computers were funded through a grant awarded by the Bill & Melinda Gates Foundation. Over time, the library staff noticed that the demand for the classes increased, so the offering of classes also increased. When the author arrived at OCLS, her…
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Social Reproduction in Non-Formal Adult Education: The Case of Rural Mozambique
ERIC Educational Resources Information Center
Straubhaar, Rolf
2014-01-01
Using fieldnotes from the non-formal adult education classes run by a non-profit international education with ground operations in rural Mozambique, this article documents how the comments made by class facilitators and class participants in those classes reflect inherent power inequalities between non-profit staff and local participants. These…
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ERIC Educational Resources Information Center
Svoboda, Victoria
2012-01-01
Researchers have explored the issue of social class in higher education through the experiences of students and faculty, but have not yet analyzed the experiences of student affairs staff. Past researchers have conflated or ignored issues of race in studies on class, and rarely acknowledge gender as a variable in the classed experience. Student…
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2016-02-12
The Food and Drug Administration (FDA) is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because a number of other devices and accessories are used with the oxygenator in the circuit, the title and identification of the regulation are revised to include extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. Although an individual device or accessory used in an ECMO circuit may already have its own classification regulation when the device or accessory is intended for short-term use (<=6 hours), such device or accessory will be subject to the same regulatory controls applied to the oxygenator (i.e., class II, special controls) when evaluated as part of the ECMO circuit for long-term use (>6 hours). On its own initiative, based on new information, FDA is revising the classification of the membrane lung device for long-term pulmonary support.
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Bohari, Mohammed H; Sastry, G Narahari
2012-09-01
Efficient drug discovery programs can be designed by utilizing existing pools of knowledge from the already approved drugs. This can be achieved in one way by repositioning of drugs approved for some indications to newer indications. Complex of drug to its target gives fundamental insight into molecular recognition and a clear understanding of putative binding site. Five popular docking protocols, Glide, Gold, FlexX, Cdocker and LigandFit have been evaluated on a dataset of 199 FDA approved drug-target complexes for their accuracy in predicting the experimental pose. Performance for all the protocols is assessed at default settings, with root mean square deviation (RMSD) between the experimental ligand pose and the docked pose of less than 2.0 Å as the success criteria in predicting the pose. Glide (38.7 %) is found to be the most accurate in top ranked pose and Cdocker (58.8 %) in top RMSD pose. Ligand flexibility is a major bottleneck in failure of docking protocols to correctly predict the pose. Resolution of the crystal structure shows an inverse relationship with the performance of docking protocol. All the protocols perform optimally when a balanced type of hydrophilic and hydrophobic interaction or dominant hydrophilic interaction exists. Overall in 16 different target classes, hydrophobic interactions dominate in the binding site and maximum success is achieved for all the docking protocols in nuclear hormone receptor class while performance for the rest of the classes varied based on individual protocol.
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Knowing Me, Knowing You: Professional Development for Support Staff
ERIC Educational Resources Information Center
Coulbeck, Joy
2009-01-01
Meeting the challenges of delivering a 21st-century curriculum and a world-class quality education ultimately depends on the willingness of the staff on the ground to give 100% effort to their jobs. Although many people in schools work very hard, some staff members are way down on the scale with regard to performance. All too often, a significant…
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Walter, Jessica R; Ghobadi, Comeron W; Hayman, Emily; Xu, Shuai
2017-01-01
In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.
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A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus.
Ekins, Sean; Freundlich, Joel S; Coffee, Megan
2014-01-01
We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.
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A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus
Ekins, Sean; Freundlich, Joel S.; Coffee, Megan
2014-01-01
We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested. PMID:25653841
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Saipetch, Chutima; Sachs, Ezekiel
2016-01-01
Abstract Purpose of review: Technological advance has revolutionized epilepsy management recently. Herein, we review some recent developments. Recent findings: Responsive neurostimulation (Food and Drug Administration [FDA]-approved 2013) works by continuous analysis of brain rhythms and direct brain stimulation on detecting patterns thought to be epileptogenic, thereby aborting seizures. Cardio-responsive vagus nerve stimulation (FDA-approved 2015) is an improvement over traditional vagus nerve stimulation systems, taking advantage of the fact that 80% of seizures are associated with tachycardia. Automated tachycardia detection leads to vagus nerve stimulation to abort seizures. In MRI-guided stereotactic laser ablation (developed 2012), a directed laser emitting fiberoptic catheter is used to ablate epileptogenic lesions. The procedure can be completed in 3 to 4 hours, potentially under local anesthesia and with next-day discharge. Perampanel (FDA-approved 2012) is a promising new class of AMPA (α-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid)-antagonist antiseizure therapy. Meanwhile, a millennia-old remedy for epilepsy, cannabis, is staging a comeback with recent legal and social permissiveness accelerating research into this use. Summary: The coming years will demonstrate how these recent advances in device and drug management will improve the care of epilepsy. PMID:29443283
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A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications
NASA Astrophysics Data System (ADS)
Rogstad, Sarah; Faustino, Anneliese; Ruth, Ashley; Keire, David; Boyne, Michael; Park, Jun
2017-05-01
The characterization sections of biologics license applications (BLAs) approved by the United States Food and Drug Administration (FDA) between 2000 and 2015 were investigated to examine the extent of the use of mass spectrometry. Mass spectrometry was found to be integral to the characterization of these biotherapeutics. Of the 80 electronically submitted monoclonal antibody and protein biotherapeutic BLAs included in this study, 79 were found to use mass spectrometric workflows for protein or impurity characterization. To further examine how MS is being used in successful BLAs, the applications were filtered based on the type and number of quality attributes characterized, the mass spectrometric workflows used (peptide mapping, intact mass analysis, and cleaved glycan analysis), the methods used to introduce the proteins into the gas phase (ESI, MALDI, or LC-ESI), and the specific types of instrumentation used. Analyses were conducted over a time course based on the FDA BLA approval to determine if any trends in utilization could be observed over time. Additionally, the different classes of protein-based biotherapeutics among the approved BLAs were clustered to determine if any trends could be attributed to the specific type of biotherapeutic.
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The Impact of a Staff Development Offering on Nursing Practice.
ERIC Educational Resources Information Center
Foglesong, Dianne H.
1983-01-01
Describes a problem-focused audit used to measure the impact of a staff development offering on pain relief. Concludes that the audit provided concrete evidence that the class on pain did influence nursing practice and affected patients directly. (NRJ)
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Moore, Thomas J; Furberg, Curt D
2014-01-01
The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. To inform the debate about appropriate standards, we studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect. Descriptive study of the drugs classified as new molecular entities using preapproval FDA evaluation documents, agency drug information databases, prescribing information, and other primary data sources. Comparison of drugs that received standard review and those deemed sufficiently innovative to receive expedited review with regard to clinical development and FDA review time, the size and duration of efficacy trials, safety issues, and postmarket follow-up. In 2008, the FDA approved 20 therapeutic drugs, 8 with expedited review and 12 with standard review. The expedited drugs took a median of 5.1 years (range, 1.6-10.6 years) of clinical development to obtain marketing approval compared with 7.5 years (range, 4.7-19.4 years) for the standard review drugs (P = .05). The expedited drugs were tested for efficacy in a median of 104 patients receiving the active drug (range, 23-599), compared with a median of 580 patients (range, 75-1207) for standard review drugs (P = .003). Nonclinical testing showed that 6 therapeutic drugs were animal carcinogens, 5 were in vitro mutagens, and 14 were animal teratogens. Other safety concerns resulted in 5 Boxed Warnings; 8 drugs required risk management plans. The FDA required 85 postmarket commitments. By 2013, 5 drugs acquired a new or expanded Boxed Warning; 26 of 85 (31%) of the postmarketing study commitments had been fulfilled, and 8 (9%) had been submitted for agency review. For new drugs approved by the FDA in 2008, those that received expedited review were approved more rapidly than those that received standard review. However, considerably fewer patients were studied prior to approval, and many safety questions remained unanswered. By 2013, many postmarketing studies had not been completed.
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2018-01-02
The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole slide imaging system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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2017-10-18
The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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2018-01-03
The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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Gauvin, David V; Zimmermann, Zachary J; Kallman, Mary Jeanne
2016-11-01
The Controlled Substances Staff of the Center for Drug Evaluation and Research at the US Food and Drug Administration and the Pharmaceutical Research Manufacturers Association (PhRMA) conducted a series of open forum dialog sessions between 2006 and 2016. A Cross Company Abuse Liability Council (CCALC) was formed during the process of this unique collaborative effort between Industry and Federal Regulators whose goals were to establish the development of standards for the preclinical screening of new molecular entities for schedule control actions required as part of every New Drug Application process. The draft guidance document was published and disseminated in 2010, which allowed for alternative approaches to each study protocol requirement needed for NDA review, if the approach satisfied the requirements of the applicable statutes and regulations (i.e., the controlled substance act). In a series of recent pre-study protocol reviews requested by confidential Pharmaceutical Sponsors of MPI Research, the CSS staff appeared to change its policy and set forth to require all drug discrimination study data to be generated under "extinction" test sessions. MPI Research is a Contract Research Organization acting on behalf of pharmaceutical companies and bound under separate confidentiality agreements. The purpose of this review is to highlight the data appearing in peer-reviewed scientific journals that do not support the regulatory administrative constraints on one specific testing methodology (extinction) to the exclusion of another (reinforced test sessions). This mind shift represents a restrictive administrative policy by the FDA that is not supported by the published data. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
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Buttery, Amanda K; Husk, Janet; Lowe, Derek; Treml, Jonathan; Vasilakis, Naomi; Riglin, Jackie
2014-05-01
falling, and fear of falling, significantly affect older people and their lifestyle resulting in loss of confidence, restriction of activity and deteriorating quality of life. Multi-factorial assessment and active participation in an evidence-based exercise programme are key interventions to prevent and manage falls. to examine older people's experiences of therapeutic exercise as part of a falls prevention service in NHS Trusts in England, Wales and Northern Ireland. a cross-sectional survey targeted patients and staff members delivering exercise interventions for reducing falls. A multi-disciplinary group including patient and staff representatives developed a 20-item patient questionnaire and a 12-item staff questionnaire that were distributed to 94 NHS Trusts (113 participating sites within the NHS Trusts) in October 2011. response was 57% for the patient sample and 88% for the staff sample. The median (IQR) age of patients was 82 (77-86) years. 72% were women. Two-thirds reported attending group-based therapeutic exercise classes generally of short duration (80% <12 weeks) and low intensity (85% one class per week) at hospitals and community venues. Balance and strength exercises were prescribed; 68% reported using resistance equipment such as ankle weights and/or exercise band. Only 52% reported exercises were made more difficult as they improved. However, patient satisfaction levels were high (95% satisfied or very satisfied). Patients and staff reported limited availability of strength and balance follow-up classes. despite high levels of patient satisfaction therapeutic exercise provision was limited and implementation of evidence-based exercise interventions by healthcare providers is incomplete and varies widely. Patients and staff wanted greater availability of long-term exercise services for falls prevention.
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Vagus nerve stimulation for the treatment of depression and other neuropsychiatric disorders.
George, Mark S; Nahas, Ziad; Borckardt, Jeffrey J; Anderson, Berry; Burns, Carol; Kose, Samet; Short, E Baron
2007-01-01
Vagus nerve stimulation is an interesting new approach to treating neuropsychiatric diseases within the class of brain-stimulation devices sometimes labeled 'neuromodulators'. With vagus nerve stimulation, a battery-powered generator implanted in the chest wall connects to a wire wrapped around the vagus nerve in the neck, and sends intermittent pulses of electricity along the nerve directly into the brain. This mechanism takes advantage of the natural role of the vagus nerve in conveying information into the brain concerning homeostatic information (e.g., hunger, chest pain and respirations). Vagus nerve stimulation therapy is US FDA approved for the adjunctive treatment of epilepsy and has recently been FDA approved for the treatment of medication-resistant depression. Owing to its novel route into the brain, it has no drug-drug interactions or systemic side effects. This treatment also appears to have high long-term tolerability in patients, with low rates of patients relapsing on vagus nerve stimulation or becoming tolerant. However, alongside the excitement and enthusiasm for this new treatment, a lack of Class I evidence of efficacy in treating depression is currently slowing down adoption by psychiatrists. Much more research is needed regarding exactly how to refine and deliver the electrical pulses and how this differentially affects brain function in health and disease.
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An interagency collaboration to facilitate development of filovirus medical countermeasures.
Kilgore, Nicole; Nuzum, Edwin O
2012-10-19
The Filovirus Animal Non-Clinical Group (FANG) is a US interdepartmental and interagency group established to support and facilitate the advanced development of filovirus Medical Countermeasures (MCM), both vaccines and therapeutics. It is co-led by one representative from the Department of Defense (DoD), the first author, and one from the Department of Health and Human Services (HHS), the second author. The FANG membership includes operational level program staff and Subject Matter Experts (SME) from performing organizations as well as scientific staff and program managers from DoD and HHS funding and regulatory agencies. Focus areas include animal models, assays, reagents, product manufacture and characterization, and other interagency product development issues that will support Food and Drug Administration (FDA) licensure of safe and effective filovirus MCMs. The FANG continues to develop strategies to address broadly applicable and interagency product development challenges relevant to filovirus MCM development. This paper summarizes FANG structure and accomplishments and is meant to heighten community awareness of this government-led collaborative effort.
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An Interagency Collaboration to Facilitate Development of Filovirus Medical Countermeasures
Kilgore, Nicole; Nuzum, Edwin O.
2012-01-01
The Filovirus Animal Non-Clinical Group (FANG) is a US interdepartmental and interagency group established to support and facilitate the advanced development of filovirus Medical Countermeasures (MCM), both vaccines and therapeutics. It is co-led by one representative from the Department of Defense (DoD), the first author, and one from the Department of Health and Human Services (HHS), the second author. The FANG membership includes operational level program staff and Subject Matter Experts (SME) from performing organizations as well as scientific staff and program managers from DoD and HHS funding and regulatory agencies. Focus areas include animal models, assays, reagents, product manufacture and characterization, and other interagency product development issues that will support Food and Drug Administration (FDA) licensure of safe and effective filovirus MCMs. The FANG continues to develop strategies to address broadly applicable and interagency product development challenges relevant to filovirus MCM development. This paper summarizes FANG structure and accomplishments and is meant to heighten community awareness of this government-led collaborative effort. PMID:23202465
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ERIC Educational Resources Information Center
Piele, Philip K.
This document shows how computer technology can aid educators in meeting demands for improved class scheduling and more efficient use of transportation resources. The first section surveys literature on operational systems that provide individualized scheduling for students, varied class structures, and maximum use of space and staff skills.…
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Using the Community as a Classroom for Large Introductory Sociology Classes.
ERIC Educational Resources Information Center
Corwin, Patricia
1996-01-01
Explores how a student service program can be implemented without a large staff and without cost, in large introductory sociology classes as part of an extra-credit project, while augmenting course material as an active learning component. Discusses a class that fits this description at North Dakota State University. (MJP)
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Adverse Effects of Nutraceuticals and Dietary Supplements.
Ronis, Martin J J; Pedersen, Kim B; Watt, James
2018-01-06
Over 70% of Americans take some form of dietary supplement every day, and the supplement industry is currently big business, with a gross of over $28 billion. However, unlike either foods or drugs, supplements do not need to be registered or approved by the US Food and Drug Administration (FDA) prior to production or sales. Under the Dietary Supplement Health and Education Act of 1994, the FDA is restricted to adverse report monitoring postmarketing. Despite widespread consumption, there is limited evidence of health benefits related to nutraceutical or supplement use in well-nourished adults. In contrast, a small number of these products have the potential to produce significant toxicity. In addition, patients often do not disclose supplement use to their physicians. Therefore, the risk of adverse drug-supplement interactions is significant. An overview of the major supplement and nutraceutical classes is presented here, together with known toxic effects and the potential for drug interactions.
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An analysis of FDA-approved drugs: natural products and their derivatives.
Patridge, Eric; Gareiss, Peter; Kinch, Michael S; Hoyer, Denton
2016-02-01
Natural products contribute greatly to the history and landscape of new molecular entities (NMEs). An assessment of all FDA-approved NMEs reveals that natural products and their derivatives represent over one-third of all NMEs. Nearly one-half of these are derived from mammals, one-quarter from microbes and one-quarter from plants. Since the 1930s, the total fraction of natural products has diminished, whereas semisynthetic and synthetic natural product derivatives have increased. Over time, this fraction has also become enriched with microbial natural products, which represent a significant portion of approved antibiotics, including more than two-thirds of all antibacterial NMEs. In recent years, the declining focus on natural products has impacted the pipeline of NMEs from specific classes, and this trend is likely to continue without specific investment in the pursuit of natural products. Copyright © 2015 Elsevier Ltd. All rights reserved.
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Christensen Brydges, Sarah; Gwozdek, Anne E
2011-01-01
The Boys & Girls Club of America (BGCA) requires a health curriculum be taught. With the assistance of the University of Michigan (UM) Dental Hygiene program, these requirements have been addressed at the Huron Valley Boys & Girls Club (HVBGC) through dental hygiene students presenting oral health education to club members throughout the year. This study assessed the outcomes and benefits of the service learning initiative between the UM Dental Hygiene Program and the HVBGC from both the students' and staffs' perceptions. Three surveys were distributed: one to the HVBGC staff, one to UM's Dental Hygiene class of 2012 (with no service learning experience at the HVBGC) and one to UM Dental Hygiene classes of 2010 and 2011 (most of whom had experience at the HVBGC). Qualitative and quantitative data were collected and evaluated. The respondents from the class of 2012 were less knowledgeable about the BGCA and access to care issues. The members of the classes of 2010 and 2011, 79% of whom had HVBGC experience, identified they had benefitted from this service learning experience. The HVBGC staff survey indicated a high level of satisfaction with the student presentations and felt their curricular requirements were being met. Future topics of safety, orthodontics and gardening/nutrition were identified. This study indicates the service learning initiative has been beneficial for both the UM Dental Hygiene students and the HVBGC. Future studies should use a longitudinal design to obtain baseline and post-service learning data.
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Zimmerman, Kanecia; Putera, Martin; Hornik, Christoph P.; Smith, P. Brian; Benjamin, Daniel K.; Mulugeta, Yeruk; Burckart, Gilbert J.; Cohen-Wolkowiez, Michael; Gonzalez, Daniel
2016-01-01
Purpose Over the last decade, few novel antibiotics have been approved by the Food and Drug Administration (FDA) for pediatric use. For most anti-infective agents, including antibiotics, extrapolation of efficacy from adults to children is possible if the disease and therapeutic exposures are similar between the 2 populations. This approach reduces the number of studies required in children, but relies heavily on exposure matching between children and adults. Failures in exposure matching can lead to delays in pediatric approvals of new anti-infective agents. We sought to determine the extent of exposure matching, defined by a comparison of area under the concentration-time curve, between children and adults, for anti-infective drug products submitted to the FDA for approval. Methods We reviewed anti-infective submissions to the FDA (2002–2014) for pediatric indication. We included drug products administered via oral, intravenous, or intramuscular administration routes, and those with AUC estimates for children in available FDA reports. Our main outcome of interest was the proportion of drugs with median (or mean) pediatric AUC within 20% of the median (or mean) reported adult value. Findings We identified 29 drug products that met inclusion criteria, 14 (48%) of which had mean (or median) AUCs of all submitted age groups within 20% of that in adults. Only route of administration and drug class were associated with pediatric AUC within 20% of adult AUC. Implications Future research is needed to define criteria for and predictors of successful exposure matching of anti-infectives between children and adults. PMID:27364807
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The Drug Facts Box: Improving the communication of prescription drug information.
Schwartz, Lisa M; Woloshin, Steven
2013-08-20
Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label--the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing--may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and "spinning" unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies--including national randomized trials--demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3-5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information.
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The Drug Facts Box: Improving the communication of prescription drug information
Schwartz, Lisa M.; Woloshin, Steven
2013-01-01
Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label—the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing—may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and “spinning” unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies—including national randomized trials—demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3–5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information. PMID:23942130
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Pradhan, Richeek; Singh, Sonal
2018-04-11
Inconsistencies in data on serious adverse events (SAEs) and mortality in ClinicalTrials.gov and corresponding journal articles pose a challenge to research transparency. The objective of this study was to compare data on SAEs and mortality from clinical trials reported in ClinicalTrials.gov and corresponding journal articles with US Food and Drug Administration (FDA) medical reviews. We conducted a cross-sectional study of a randomly selected sample of new molecular entities approved during the study period 1 January 2013 to 31 December 2015. We extracted data on SAEs and mortality from 15 pivotal trials from ClinicalTrials.gov and corresponding journal articles (the two index resources), and FDA medical reviews (reference standard). We estimated the magnitude of deviations in rates of SAEs and mortality between the index resources and the reference standard. We found deviations in rates of SAEs (30% in ClinicalTrials.gov and 30% in corresponding journal articles) and mortality (72% in ClinicalTrials.gov and 53% in corresponding journal articles) when compared with the reference standard. The intra-class correlation coefficient between the three resources was 0.99 (95% confidence interval [CI] 0.98-0.99) for SAE rates and 0.99 (95% CI 0.97-0.99) for mortality rates. There are differences in data on rates of SAEs and mortality in randomized clinical trials in both ClinicalTrials.gov and journal articles compared with FDA reviews. Further efforts should focus on decreasing existing discrepancies to enhance the transparency and reproducibility of data reporting in clinical trials.
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Zimmerman, Kanecia; Putera, Martin; Hornik, Christoph P; Brian Smith, P; Benjamin, Daniel K; Mulugeta, Yeruk; Burckart, Gilbert J; Cohen-Wolkowiez, Michael; Gonzalez, Daniel
2016-09-01
Over the last decade, few new antibiotics have been approved by the Food and Drug Administration (FDA) for pediatric use. For most anti-infective agents, including antibiotics, extrapolation of efficacy from adults to children is possible if the disease and therapeutic exposures are similar between the 2 populations. This approach reduces the number of studies required in children, but relies heavily on exposure matching between children and adults. Failures in exposure matching can lead to delays in pediatric approvals of new anti-infective agents. We sought to determine the extent of exposure matching, defined by a comparison of area under the concentration-time curve, between children and adults, for anti-infective drug products submitted to the FDA for approval. We reviewed anti-infective submissions to the FDA (2002-2014) for pediatric indication. We included drug products administered via oral, intravenous, or intramuscular administration routes, and those with AUC estimates for children in available FDA reports. Our main outcome of interest was the proportion of drugs with median (or mean) pediatric AUC within 20% of the median (or mean) reported adult value. We identified 29 drug products that met inclusion criteria, 14 (48%) of which had mean (or median) AUCs of all submitted age groups within 20% of that in adults. Only route of administration and drug class were associated with pediatric AUC within 20% of adult AUC. Future research is needed to define criteria for and predictors of successful exposure matching of anti-infectives between children and adults. Published by Elsevier Inc.
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Mulinari, Shai; Davis, Courtney
2017-11-09
Relenza represents the first neuraminidase inhibitor (NI), a class of drugs that also includes the drug Tamiflu. Although heralded as breakthrough treatments in influenza, NI efficacy has remained highly controversial. A key unsettled question is why the United States Food and Drug Administration (FDA) has approved more cautious efficacy statements in labelling than European regulators for both drugs. We conducted a qualitative analysis of United States and European Union regulatory appraisals for Relenza to investigate the reasons for divergent regulatory interpretations, pertaining to Relenza's capacity to alleviate symptoms and reduce frequency of complications of influenza. In Europe, Relenza was evaluated via the so-called national procedure with Sweden as the reference country. We show that FDA reviewers, unlike their European (i.e. Swedish) counterpart, (1) rejected the manufacturer's insistence on pooling efficacy data, (2) remained wary of subgroup analyses, and (3) insisted on stringent statistical analyses. These differences meant that the FDA was less likely to depart from prevailing regulatory and scientific standards in interpreting trial results. We argue that the differences are explained largely by divergent institutionalised review methodologies, i.e. the European regulator's reliance on manufacturer-compiled summaries compared to the FDA's examination of original data and documentation from trials. The FDA's more probing and meticulous evaluative methodology allowed its reviewers to develop 'deep' knowledge concerning the clinical and statistical facets of trials, and more informed opinions regarding suitable methods for analysing trial results. These findings challenge the current emphasis on evaluating regulatory performance mainly in terms of speed of review. We propose that persistent uncertainty and knowledge deficits regarding NIs could have been ameliorated had regulators engaged in the public debates over the drugs' efficacy and explained their contrasting methodologies and judgments. Regulators use major resources to evaluate drugs, but if regulators' assessments are not effectively disseminated and used, resources are used inefficiently.
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FDA toxicity databases and real-time data entry.
Arvidson, Kirk B
2008-11-15
Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.
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Education in a homeless shelter to improve the nutrition of young children.
Yousey, Yvonne; Leake, Jacquelyn; Wdowik, Melissa; Janken, Janice K
2007-01-01
To improve the nutritional status of homeless children by implementing an educational program for their mothers and the cafeteria staff at a homeless shelter. Program evaluation including before and after measures of mothers' nutritional knowledge and nutritional quality of foods served in the cafeteria. Fifty-six mothers with children aged 18 months to 6 years and 3 cafeteria staff. Four nutrition classes developed by a registered nutritionist were taught to mothers by clinic nurses; 3 nutrition classes were taught to the cafeteria staff by the nutritionist. Mothers scored higher on posttests than on pretests, indicating improved nutritional knowledge. Minimal differences in the nutritional quality of foods served to residents were observed after staff education. This project demonstrates the challenges of altering the nutritional status of children in a homeless shelter. Despite mothers showing better knowledge of nutritional requirements for children, the types of food served in the cafeteria were an obstacle to them in practicing what they had learned. The cafeteria staff's ability to demonstrate their learning was impeded by the constraints of food donations. Educational strategies may need to be augmented by policies to improve the nutritional status of children in homeless shelters.
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Is There Evidence to Support Brand to Generic Interchange of the Mycophenolic Acid Products?
Phillips, Karen; Reddy, Prabashni; Gabardi, Steven
2017-02-01
The uptake of generic immunosuppressants lags comparatively to other drug classes, despite that the Food and Drug Administration (FDA) uses identical bioequivalence standards for all drugs. Transplant societies acknowledge the cost savings associated with generic immunosuppressants and support their use following heart, lung, kidney, or bone marrow transplantation. Seven studies of the pharmacokinetics or clinical efficacy of generic mycophenolate mofetil compared to the innovator product are published; all studies and products were ex-United States. Three studies did not demonstrate any pharmacokinetic differences between generic and innovator products in healthy subjects, achieving FDA bioequivalence requirements. Two studies in renal allograft recipients demonstrated no difference in area under the curves between generic and innovator products, and in one, the maximum concentration (Cmax) fell outside the FDA regulatory range. Two studies revealed no difference in acute organ rejection or graft function in renal allograft recipients. Patient surveys indicate that cost is a barrier to immunosuppressant adherence. Generics present a viable method to reduce costs to payers, patients, and health care systems. Adherence to immunosuppressants is crucial to prevent graft failure. An affordable regimen potentially confers greater adherence. Concerns regarding the presumed inferiority of generic immunosuppressants should be assuaged by regulatory requirements for bioequivalency testing, transplant society position statements, and pharmacokinetic and clinical studies.
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A Class Act? Lecturers' Views on Undergraduates' Employability
ERIC Educational Resources Information Center
Morrison, Andrew
2014-01-01
This article details the findings of a study into lecturers' perceptions of undergraduate employability. The investigation employed interviews with the staff on a BA (Hons) in Education Studies course at a post-1992 university. The aim was to examine staff beliefs regarding their students' potential employability in the business and finance…
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Tasting Wine: A Learning Experience
ERIC Educational Resources Information Center
King, Tanya J.; Donaldson, Jilleen A.; Harry, Emma
2012-01-01
This paper describes a field trip by senior undergraduate anthropology students to a local winery, where they participated in a wine-tasting class with winery staff. In response to explicit hints from a wine-tasting facilitator, and more subtle cues from the cultural capital embedded in their surroundings and the winery staff, the students…
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Kansas Rural Schools and Education Service Centers : A 21st Century Solution.
ERIC Educational Resources Information Center
Cook, Rita C.
2003-01-01
Rural Kansas schools facing financial problems and demands for more accountability must cooperate to survive. Smoky Hill Education Service Center, representing 45 school districts, provides on-site staff development and online classes for students and staff, maintains a multimedia library, has a cooperative purchasing program, provides…
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From old alkylating agents to new minor groove binders.
Puyo, Stéphane; Montaudon, Danièle; Pourquier, Philippe
2014-01-01
Alkylating agents represent the oldest class of anticancer agents with the approval of mechloretamine by the FDA in 1949. Even though their clinical use is far beyond the use of new targeted therapies, they still occupy a major place in the treatment of specific malignancies, sometimes representing the unique option for the treatment of refractory tumors. Here, we are reviewing the major classes of alkylating agents, with a particular focus on the latest generations of compounds that specifically target the minor groove of the DNA. These naturally occurring derivatives have a unique mechanism of action that explains the recent regain of interest in developing new classes of alkylating agents that could be used in combination with other anticancer drugs to enhance tumor response in the clinic. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-19
... option class (a ``Post-Halt Notification'') following a regulatory halt, trading pause or market-wide trading halt. Currently, the Exchange's Trading Operations staff at the MIAX Help Desk issues a Post-Halt...(a). The Post-Halt Notification states the time at which trading in the option class or classes is...
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Kleitman, Naomi; Rao, Mahendra S; Owens, David F
2013-07-01
Recently, the U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health, and the stem cell research community have collaborated on a series of workshops that address moving pluripotent stem cell therapies into the clinic. The first two workshops in the series focused on preclinical science, and a third, future workshop will focus on clinical trials. This summary addresses major points from both of the recent preclinically focused meetings. When entering into a therapeutics developmental program based on pluripotent cells, investigators must make decisions at the very early stages that will have major ramifications during later phases of development. Presentations and discussions from both invited participants and FDA staff described the need to characterize and document the quality, variability, and suitability of the cells and commercial reagents used at every translational stage. This requires consideration of future regulatory requirements, ranging from donor eligibility of the original source material to the late-stage manufacturing protocols. Federal, industrial, and academic participants agreed that planning backward is the best way to anticipate what evidence will be needed to justify human testing of novel therapeutics and to eliminate wasted efforts.
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Kleitman, Naomi; Owens, David F.
2013-01-01
Recently, the U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health, and the stem cell research community have collaborated on a series of workshops that address moving pluripotent stem cell therapies into the clinic. The first two workshops in the series focused on preclinical science, and a third, future workshop will focus on clinical trials. This summary addresses major points from both of the recent preclinically focused meetings. When entering into a therapeutics developmental program based on pluripotent cells, investigators must make decisions at the very early stages that will have major ramifications during later phases of development. Presentations and discussions from both invited participants and FDA staff described the need to characterize and document the quality, variability, and suitability of the cells and commercial reagents used at every translational stage. This requires consideration of future regulatory requirements, ranging from donor eligibility of the original source material to the late-stage manufacturing protocols. Federal, industrial, and academic participants agreed that planning backward is the best way to anticipate what evidence will be needed to justify human testing of novel therapeutics and to eliminate wasted efforts. PMID:23757505
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Downing, Nicholas S.; Shah, Nilay D.; Aminawung, Jenerius A.; Pease, Alison M.; Zeitoun, Jean-David; Krumholz, Harlan M.
2017-01-01
Importance Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. Objectives To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Design and Setting Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Exposures Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near–regulatory deadline approval, and regulatory review time. Main Outcomes and Measures A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. Results From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near–regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were statistically significantly less frequent among those with regulatory review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02). Conclusions and Relevance Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle. PMID:28492899
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Downing, Nicholas S; Shah, Nilay D; Aminawung, Jenerius A; Pease, Alison M; Zeitoun, Jean-David; Krumholz, Harlan M; Ross, Joseph S
2017-05-09
Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near-regulatory deadline approval, and regulatory review time. A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near-regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were statistically significantly less frequent among those with regulatory review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02). Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near-regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.
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2017-12-27
The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the flow cytometric test system for hematopoietic neoplasms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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2014-09-03
The Food and Drug Administration (FDA) is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the early growth response 1 (EGR1) gene fluorescence in-site hybridization (FISH) test system for specimen characterization classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Profiling structured product labeling with NDF-RT and RxNorm
2012-01-01
Background Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by United States Food and Drug Administration (FDA) as a mechanism for exchanging drug product information. The SPL drug labels contain rich information about FDA approved clinical drugs. However, the lack of linkage to standard drug ontologies hinders their meaningful use. NDF-RT (National Drug File Reference Terminology) and NLM RxNorm as standard drug ontology were used to standardize and profile the product labels. Methods In this paper, we present a framework that intends to map SPL drug labels with existing drug ontologies: NDF-RT and RxNorm. We also applied existing categorical annotations from the drug ontologies to classify SPL drug labels into corresponding classes. We established the classification and relevant linkage for SPL drug labels using the following three approaches. First, we retrieved NDF-RT categorical information from the External Pharmacologic Class (EPC) indexing SPLs. Second, we used the RxNorm and NDF-RT mappings to classify and link SPLs with NDF-RT categories. Third, we profiled SPLs using RxNorm term type information. In the implementation process, we employed a Semantic Web technology framework, in which we stored the data sets from NDF-RT and SPLs into a RDF triple store, and executed SPARQL queries to retrieve data from customized SPARQL endpoints. Meanwhile, we imported RxNorm data into MySQL relational database. Results In total, 96.0% SPL drug labels were mapped with NDF-RT categories whereas 97.0% SPL drug labels are linked to RxNorm codes. We found that the majority of SPL drug labels are mapped to chemical ingredient concepts in both drug ontologies whereas a relatively small portion of SPL drug labels are mapped to clinical drug concepts. Conclusions The profiling outcomes produced by this study would provide useful insights on meaningful use of FDA SPL drug labels in clinical applications through standard drug ontologies such as NDF-RT and RxNorm. PMID:23256517
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Profiling structured product labeling with NDF-RT and RxNorm.
Zhu, Qian; Jiang, Guoqian; Chute, Christopher G
2012-12-20
Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by United States Food and Drug Administration (FDA) as a mechanism for exchanging drug product information. The SPL drug labels contain rich information about FDA approved clinical drugs. However, the lack of linkage to standard drug ontologies hinders their meaningful use. NDF-RT (National Drug File Reference Terminology) and NLM RxNorm as standard drug ontology were used to standardize and profile the product labels. In this paper, we present a framework that intends to map SPL drug labels with existing drug ontologies: NDF-RT and RxNorm. We also applied existing categorical annotations from the drug ontologies to classify SPL drug labels into corresponding classes. We established the classification and relevant linkage for SPL drug labels using the following three approaches. First, we retrieved NDF-RT categorical information from the External Pharmacologic Class (EPC) indexing SPLs. Second, we used the RxNorm and NDF-RT mappings to classify and link SPLs with NDF-RT categories. Third, we profiled SPLs using RxNorm term type information. In the implementation process, we employed a Semantic Web technology framework, in which we stored the data sets from NDF-RT and SPLs into a RDF triple store, and executed SPARQL queries to retrieve data from customized SPARQL endpoints. Meanwhile, we imported RxNorm data into MySQL relational database. In total, 96.0% SPL drug labels were mapped with NDF-RT categories whereas 97.0% SPL drug labels are linked to RxNorm codes. We found that the majority of SPL drug labels are mapped to chemical ingredient concepts in both drug ontologies whereas a relatively small portion of SPL drug labels are mapped to clinical drug concepts. The profiling outcomes produced by this study would provide useful insights on meaningful use of FDA SPL drug labels in clinical applications through standard drug ontologies such as NDF-RT and RxNorm.
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Patent life of antiretroviral drugs approved in the US from 1987 to 2007.
Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique
2009-06-01
This study analyzes the effective patent life of antiretroviral (ARV) new molecular entities (NMEs) approved for marketing in the United States (US) between 1987 and 2007. The study includes all NMEs approved during the study period with at least one patent listed in the Orange Book (OB). Drugs discontinued from the market were excluded from the analysis. Data sources are the US Food and Drug Administration (FDA) and the US Patent and Trademark Office. A comparison between the effective patent life of ARV NMEs and NMEs from other therapeutic classes was performed. The first and last patents were used to estimate the minimum and maximum effective patent life of NMEs. Group differences were assessed using group comparison t-tests, Chi-Square and Fishers' exact tests. The FDA approved 547 NMEs during the study period; 153 NMEs did not have a patent listed in the OB or were discontinued from the US market. The patent analysis included 22 ARV NMEs and 372 other NMEs. ARV MNEs had a range from 1 to 15 patents listed in the OB. The FDA new drug application (NDA) review time was shorter for ARVs (5.8+/-2.3 months) than for other NMEs (23.6+/-18.7 months). ARV NMEs had an average of 13.2+/-3.8 years of effective patent life for the first patent versus 11.0+/-4.2 years for other NMEs. ARV NMEs had an average of 17.5+/-3.6 years of effective patent life for the last patent versus the 14.8+/-4.8 years for other NMEs. The effective patent life listed for the last patent of seven ARV NMEs (31.8%) exceeded 20 years. Shortening the drug approval process increased the effective patent life of ARVs and facilitated faster entry of new drugs into the market. ARVs had an average of 2-3 more years of effective patent life than other therapeutic classes and, therefore, a longer period without generic competition.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-21
... infusion pump stand, which is currently classified as a class I device because it supports the intended use of an infusion pump (class II medical device). A mobile medical app that simply supports the intended...
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Group 13 1990 ASCAN Ochoa talks to NASA staff pilot during T-38A training
NASA Technical Reports Server (NTRS)
1990-01-01
Astronaut candidate (ASCAN) Ellen Ochoa reviews T-38A flight procedures with a NASA staff pilot while standing on an Ellington Field runway. Later, Ochoa, along with classmates from the Group 13 1990 Astronaut class, took a T-38A familiarization flight. Ellington Field is located near JSC.
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Fire Resistance Testing of Bulkhead and Deck Penetrations. Phase 2
1988-12-01
thick steel plate. All sample 12 construction was representative of Class A-0 construction. The UL staff secured insulation ( rockwool batts) to the...designated side of the steel plates and penetrants for testing as Class A-60 deck assemblies. The rockwool batts complied with the Class A-60...insulated with rockwool batts and tested for a Class A-60 rating. This group consisted of one steel penetration, eight copper penetrations, four PVC
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ERIC Educational Resources Information Center
Woolf, Alison
2011-01-01
"Everyone Playing in Class" is an unstructured free play based provision for small classes or groups. The intervention involves training staff in attachment theory, presenting up-to-date research findings on the role of play in emotional well-being and relationship building, as well as teaching reflective communication skills. In this…
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Software Training Classes Now Open | Poster
By Nancy Parrish, Staff Writer Data Management Services, Inc. (DMS), has announced the opening of its spring session of software training classes, available to all employees at NCI at Frederick. Classes begin on March 31 and run through June 30.
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Reporting guide for laser-light shows and displays (21 CFR 1002)
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
The guide is to be used for reporting laser-light shows or displays incorporating Class IIIb or Class IV lasers only. Separate reports are not required for shows or displays that incorporate Class I, IIa, II, or IIIa laser-projection systems. Such show descriptions must be included in the user instructions and the report for the laser projector. Laser projectors used in any light shows or displays regardless of the class of the projector must be certified by the manufacturer and reported using the guide titled, Guide for Preparing Initial Reports and Model Change Reports on Lasers and Products Containing Lasers, HHSmore » Publication FDA 86-8259. These guides assist manufacturers in providing the information that the Center for Devices and Radiological Health (CDRH) needs to determine how laser-light-shown projections and laser-light shows comply with the Federal standard for laser products (21 CDR 1040.10 and 1040.11) and with the conditions of an approved variance.« less
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Brooks, Steven S
2017-06-01
Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices. Inherent device properties and the procedural risk of the devices will determine the rigor with which they are scrutinized by FDA, and the evidentiary requirements to legally market them. Data and evidentiary development will vary depending on risk and regulatory precedent and may or may not require clinical data This regulatory paradigm will determine into which risk-based device class they fit, and whether they are regulated under the 510(k) or premarket approval application pathways. The FDA, although gatekeeper of the US market and tasked with determining which products are safe and effective, can be a powerful ally for product development. They have significant scientific and medical expertise, and mechanisms to both provide guidance, and also to consider novel approaches to product development and evidence development. Early interaction for routine and novel products alike can result in expedited and efficient development. This collaborative approach can be best practice to most expeditiously develop the next generation of products, getting them into the hands of US doctors and into the treatment of US patients. Copyright © 2017. Published by Elsevier Inc.
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Chrysant, S G
2017-03-01
Patients with type 2 diabetes mellitus (T2DM) exhibit an increased risk of cardiovascular (CV) events. Treatment of these patients with traditional as well as newer glucose-lowering drugs has not demonstrated superiority in CV outcomes compared to placebo, despite effective control of diabetes. However, the recently FDA-approved sodium-glucose cotransporter 2 (SGLT2) inhibitors for the treatment of T2DM have demonstrated promising CV-protecting and blood pressure-lowering effects in addition to their effectiveness in glucose lowering, making them a novel class of drugs for the treatment of T2DM. So far, there are three SGLT2 inhibitors approved by the FDA and EMA for the treatment of T2DM: canagliflozin, dapagliflozin and empagliflozin. They exert their antihyperglycemic effect through inhibition of SGLT2 in the kidney and significantly reduce glucose reabsorption from the proximal renal tubule. By blocking glucose reabsorption, they lead to loss of calories, weight, abdominal and total body fat, blood pressure and CV complications. One CV outcomes randomized trial and several short-term studies have shown reductions in CV events and blood pressure in patients with T2DM. It is the hope that large ongoing long-term outcome studies will provide further much-needed information, when they are completed. Copyright 2017 Clarivate Analytics.
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Ahuja, Vishal; Sohn, Min-Woong; Birge, John R; Syverson, Chad; Budiman-Mak, Elly; Emanuele, Nicholas; Cooper, Jennifer M; Huang, Elbert S
2015-12-01
Geographic variation in the use of prescription drugs, particularly those deemed harmful by the FDA, may lead to variation in patient exposure to adverse drug events. One such drug is the glucose-lowering drug rosiglitazone, for which the FDA issued a safety alert on May 21, 2007, following the publication of a meta-analysis that suggested a 43% increase in the risk of myocardial infarction with the use of rosiglitazone. This alert was followed by a black box warning on August 14, 2007, that was updated 3 months later. While large declines have been documented in rosiglitazone use in clinical practice, little is known about how the use of rosiglitazone and other glucose-lowering drugs varied within the Department of Veterans Affairs (VA), surrounding the FDA alerts. Understanding this variation within integrated health care systems is essential to formulating policies that enhance patient protection and quality of care. To document variation in the use of rosiglitazone and other glucose- lowering drugs across 21 Veterans Integrated Service Networks (VISNs). We conducted a retrospective analysis of drug use patterns for all major diabetes drugs in a national cohort of 550,550 veterans with diabetes from 2003 to 2008. This included the time periods when rosiglitazone was added to (November 2003) and removed from (October 2007) the VA national formulary (VANF). We employed multivariable logistic regression models to statistically estimate the association between a patient's location and the patient's odds of using rosiglitazone. Aggregate rosiglitazone use increased monotonically from 7.7%, in the quarter it was added to the VANF (November 4, 2003), to a peak of 15.3% in the quarter when the FDA issued the safety alert. Rosiglitazone use decreased sharply afterwards, reaching 3.4% by the end of the study period (September 30, 2008). The use of pioglitazone, another glucose-lowering drug in the same class as rosiglitazone, was low when the FDA issued the safety alert (0.4%) but increased sharply afterwards, reaching 3.6% by the end of the study period. Insulin use increased monotonically; metformin use remained relatively flat; and sulfonylurea use exhibited a general declining trend throughout the study period. Statistically significant geographic variation was observed in rosiglitazone use throughout the study period. The prevalence range, defined as the range of minimum to maximum use across VISNs was 3.7%-12.4% in the first quarter (January 1 to March 31, 2003); 1.0%-5.5% in the last quarter of study period (July 1 to September 30, 2008); and reached a peak of 9.6%-25.5% in the quarter when the FDA safety alert was issued (April 1 to March 31, 2007). In 5 VISNs, peak rosiglitazone use occurred before the FDA issued the safety alert. The odds ratio of using rosiglitazone in a given VISN varied from 0.55 (95% CI = 0.52-0.59; VISN 10) to 1.58 (95% CI = 1.50-1.66; VISN 15), with VISN 1 being the reference region. The variation was higher in the periods after the FDA issued the safety alert. Much less variation was observed in the use of pioglitazone, metformin, sulfonylurea, and insulin. Our results show statistically significant variation in the way VISNs within the VA responded to the FDA alerts, suggesting a need for mechanisms that disseminate information and guidelines for drug use in a consistent and reliable manner. Further study of regions that adopted ideal practices earlier may provide lessons for regional leadership and practice culture within integrated health care systems.
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Novel ocular antihypertensive compounds in clinical trials
Chen, June; Runyan, Stephen A; Robinson, Michael R
2011-01-01
Introduction: Glaucoma is a multifactorial disease characterized by progressive optic nerve injury and visual field defects. Elevated intraocular pressure (IOP) is the most widely recognized risk factor for the onset and progression of open-angle glaucoma, and IOP-lowering medications comprise the primary treatment strategy. IOP elevation in glaucoma is associated with diminished or obstructed aqueous humor outflow. Pharmacotherapy reduces IOP by suppressing aqueous inflow and/or increasing aqueous outflow. Purpose: This review focuses on novel non-FDA approved ocular antihypertensive compounds being investigated for IOP reduction in ocular hypertensive and glaucoma patients in active clinical trials within approximately the past 2 years. Methods: The mode of IOP reduction, pharmacology, efficacy, and safety of these new agents were assessed. Relevant drug efficacy and safety trials were identified from searches of various scientific literature databases and clinical trial registries. Compounds with no specified drug class, insufficient background information, reformulations, and fixed-combinations of marketed drugs were not considered. Results: The investigational agents identified comprise those that act on the same targets of established drug classes approved by the FDA (ie, prostaglandin analogs and β-adrenergic blockers) as well as agents belonging to novel drug classes with unique mechanisms of action. Novel targets and compounds evaluated in clinical trials include an actin polymerization inhibitor (ie, latrunculin), Rho-associated protein kinase inhibitors, adenosine receptor analogs, an angiotensin II type 1 receptor antagonist, cannabinoid receptor agonists, and a serotonin receptor antagonist. Conclusion: The clinical value of novel compounds for the treatment of glaucoma will depend ultimately on demonstrating favorable efficacy and benefit-to-risk ratios relative to currently approved prostaglandin analogs and β-blockers and/or having complementary modes of action. PMID:21629573
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FDA toxicity databases and real-time data entry
DOE Office of Scientific and Technical Information (OSTI.GOV)
Arvidson, Kirk B.
Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributedmore » in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.« less
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ERIC Educational Resources Information Center
Skyrme, Gillian; McGee, Alyson
2016-01-01
This article reports on an interview-based study of the academic practices of staff members in a New Zealand university in response to international students in their classes and under their supervision. International students enter academic cultures which are inevitably different from those which have provided their academic preparation.…
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The Relationship Between Staff Development and Health Instruction in Schools in the United States
ERIC Educational Resources Information Center
Jones, Sherry Everett; Brener, Nancy D.; McManus, Tim
2004-01-01
This analysis examined differences in health instruction among teachers of required health education classes or courses who had received or wanted staff development on health topics, teachers who had a degree in health education, and teachers who were Certified Health Education Specialists. Classroom-level data were collected from teachers of a…
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Judgments of Successful Inclusion by Education Service Personnel
ERIC Educational Resources Information Center
Frederickson, Norah; Osborne, Lisa A.; Reed, Phil
2004-01-01
Three different methods were used to investigate the basis of judgments about the success of inclusion made by key staff in an education service in the UK. First, a structured questionnaire was used by staff to rate the pupil social and learning skills needed for success in mainstream classes. Second, an open-ended elicitation technique was used…
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ERIC Educational Resources Information Center
Bereznicki, Hannah; Sutherland-Smith, Wendy; Horwood, Sharon
2014-01-01
Much of the burden of undergraduate teaching in Australian higher education institutions falls to sessional staff and postgraduate students. These members of staff assume high teaching loads and administrative management responsibilities. This paper explores the perspectives of two female academics in the unique position of being the subject…
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2017-12-20
The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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FDA-approved medications that impair human spermatogenesis.
Ding, Jiayi; Shang, Xuejun; Zhang, Zhanhu; Jing, Hua; Shao, Jun; Fei, Qianqian; Rayburn, Elizabeth R; Li, Haibo
2017-02-07
We herein provide an overview of the single-ingredient U.S. Food and Drug Administration (FDA)-approved drugs that affect human spermatogenesis, potentially resulting in a negative impact on male fertility. To provide this information, we performed an in-depth search of DailyMed, the official website for FDA-approved drug labels. Not surprisingly, hormone-based agents were found to be the drugs most likely to affect human spermatogenesis. The next category of drugs most likely to have effects on spermatogenesis was the antineoplastic agents. Interestingly, the DailyMed labels indicated that several anti-inflammatory drugs affect spermatogenesis, which is not supported by the peer-reviewed literature. Overall, there were a total of 65 labels for drugs of various classes that showed that they have the potential to affect human sperm production and maturation. We identified several drugs indicated to be spermatotoxic in the drug labels that were not reported in the peer-reviewed literature. However, the details about the effects of these drugs on human spermatogenesis are largely lacking, the mechanisms are often unknown, and the clinical impact of many of the findings is currently unclear. Therefore, additional work is needed at both the basic research level and during clinical trials and post-marketing surveillance to fill the gaps in the current knowledge. The present findings will be of interest to physicians and pharmacists, researchers, and those involved in drug development and health care policy.
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2015-01-01
Fatty acid synthase (FASN), the enzyme responsible for de novo synthesis of free fatty acids, is up-regulated in many cancers. FASN is essential for cancer cell survival and contributes to drug resistance and poor prognosis. However, it is not expressed in most nonlipogenic normal tissues. Thus, FASN is a desirable target for drug discovery. Although different FASN inhibitors have been identified, none has successfully moved into clinical use. In this study, using in silico screening of an FDA-approved drug database, we identified proton pump inhibitors (PPIs) as effective inhibitors of the thioesterase activity of human FASN. Further investigation showed that PPIs inhibited proliferation and induced apoptosis of cancer cells. Supplementation of palmitate, the end product of FASN catalysis, rescued cancer cells from PPI-induced cell death. These findings provide new evidence for the mechanism by which this FDA-approved class of compounds may be acting on cancer cells. PMID:25513712
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Toxicological Differences Between NMDA Receptor Antagonists and Cholinesterase Inhibitors.
Shi, Xiaodong; Lin, Xiaotian; Hu, Rui; Sun, Nan; Hao, Jingru; Gao, Can
2016-08-01
Cholinesterase inhibitors (ChEIs), represented by donepezil, rivastigmine, and galantamine, used to be the only approved class of drugs for the treatment of Alzheimer's disease. After the approval of memantine by the Food and Drug Administration (FDA), N-methyl-d-aspartic acid (NMDA) receptor antagonists have been recognized by authorities and broadly used in the treatment of Alzheimer's disease. Along with complementary mechanisms of action, NMDA antagonists and ChEIs differ not only in therapeutic effects but also in adverse reactions, which is an important consideration in clinical drug use. And the number of patients using NMDA antagonists and ChEIs concomitantly has increased, making the matter more complicated. Here we used the FDA Adverse Event Reporting System for statistical analysis , in order to compare the adverse events of memantine and ChEIs. In general, the clinical evidence confirmed the safety advantages of memantine over ChEIs, reiterating the precautions of clinical drug use and the future direction of antidementia drug development. © The Author(s) 2016.
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DiMasi, Joseph A
2013-06-01
Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean approval-phase time during the study period for applications that received a standard review rating from the FDA was substantially shorter for supplements compared to original uses, but the differences for applications that received a priority review rating from the FDA were negligible. Development of and regulatory approval for new uses of already-approved drugs and biologics is an important source of innovation by biopharmaceutical firms. Despite rising development costs, the output of new-use approvals has remained stable in recent years, driven largely by the pursuit of new pediatric indications. FDA approval-phase times have generally declined substantially for all types of applications since the mid-1990s following legislation that provided a new source of income for the agency. However, while the resources needed to review supplemental applications are likely lower in general than for original-use approvals, the approval-phase times for important new uses are no lower than for important original-use applications. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.
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Early abortion services in the United States: a provider survey.
Benson, Janie; Clark, Kathryn Andersen; Gerhardt, Ann; Randall, Lynne; Dudley, Susan
2003-04-01
The objective of this study was to describe the availability of early surgical and medical abortion among members of the National Abortion Federation (NAF) and to identify factors affecting the integration of early abortion services into current services. Telephone interviews were conducted with staff at 113 Planned Parenthood affiliates and independent abortion providers between February and April 2000, prior to FDA approval of mifepristone. Early abortion services were available at 59% of sites, and establishing services was less difficult than or about what was anticipated. Sites generally found it easier to begin offering early surgical abortion than early medical abortion. Physician participation was found to be critical to implementing early services. At sites where some but not all providers offered early abortion, variations in service availability resulted. Given the option of reconsidering early services, virtually all sites would make the same decision again. These data suggest that developing mentoring relationships between experienced early abortion providers/sites and those not offering early services, and training physicians and other staff, are likely to be effective approaches to expanding service availability.
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Guaranteeing the Course Schedule
ERIC Educational Resources Information Center
Carroll, Jonathan; Campbell, Lea
2008-01-01
It is an event administrators, faculty, staff, and students dread every semester--the course cancellation meeting, when it is decided which low enrollment classes will be canceled. No one wins. Students are left scrambling to make last-minute adjustments to their schedules, and administrators are forced to cancel low-enrollment classes even though…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-25
...: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled, ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities.'' This guidance document was developed as a special control to support the reclassification of the topical oxygen...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-17
...: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Class II Special Controls Guidance Document: External Pacemaker Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the...
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(Updated) Students, Teachers Share Technology Now Advantages with ATRF Staff | Poster
By Carolynne Keenan, Contributing Writer Philip Evich, a senior at Middletown High School, loves talking about literature, even beyond the allotted 90 minutes of his Advanced Placement (AP) Literature class. That’s why he and his classmates embraced the opportunity to blog about books read in the class.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-20
...: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration... the guidance entitled, ``Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' This guidance document describes a means by which focused ultrasound...
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Edmonson, James M
2009-01-01
The Dittrick Museum of Medical History pursues an educational mission as being part of a major research university. While the Dittrick dates to 1899 as a historical committee of the Cleveland Medical Library Association, it first affiliated with Case Western Reserve University in 1966, and became a department of the College of Arts and Sciences of CWRU in 1998. The Dittrick maintains a museum exhibition gallery that is open to the public free of charge, and museum staff provide guided tours on appointment. Much of the teaching and instruction at the Dittrick is conducted by university professors; their classes meet in the museum and use museum resources in the form of artifacts, images, archives, and rare books. Class projects using Dittrick collections may take the form of research papers, exhibitions, and online presentations. Dittrick staff assist in these classes and are available to help researchers use museum resources.
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The Training Process of the Organization Development and Training Office
NASA Technical Reports Server (NTRS)
Johnson, Melissa S.
2004-01-01
The Organization Development and Training Office provides training and development opportunities to employees at NASA Glenn Research Center, as a division of the Office of Human Resources and Workforce Planning. Center-wide required trainings, new employee trainings, workshops and career development programs are organized by the OD&TO staff. They also arrange all academic, non-academic, headquarters, fellowship and learning center sponsored courses. They also service organizations wishing to work more effectively by facilitating teambuilding exercises. Equal Opportunity programs and upward mobility programs such as the STEP and GO programs for administrative staff. In working with my mentor I am very involved with Cuyahoga Community College classes, mandatory supervisory training and administrative staff workshops. My largest tasks are in the secretarial training category. The Supporting Organizations And Relationships workshop for administrative personnel, commonly known as SOAR, began last year and continued this summer with follow-up workshops. Months before a workshop or class is brought to Glenn, a need has to be realized. In this case, administrative staff did not feel they had an opportunity to receive relevant training and develop skills through teambuilding, networking and communication. A Statement of work is then created as several companies are contacted about providing the training. After the company best suited to meet the target group s needs is selected, the course is announced with an outline of all pertinent information. A reservation for a facility is made and applications or nominations, depending on the announcement s guidelines, are received from interested employees. Confirmations are sent to participants and final preparations are made but there are still several concluding steps. A training office staff member also assists the facilitator with setting up the facility and introducing the class. After the class, participants evaluations are read and summarized to determine the effectiveness of the class and instructor. In addition to the SOAR workshops, I have several projects and daily tasks to complete. Coding training applications, which require me to be familiar with Glenn s budgetary allocations and policies on training, is an ongoing process. It also requires verifying information reported by an employee via her C-478 form, more commonly known as the training application. I am also the point of contact for the Cuyahoga Community College Advising Sessions held here at NASA Glenn which involves coordinating counselors visits with employees schedules. Two databases had to be created. The first database holds information on administrative staff, and the other tracks supervisors training histories. Through these assignments I gained experience in Microsoft Access 2002 and spreadsheet creation, communicating with co-workers, and successfully facilitating a training to serve specific purposes. With trainings and evaluations to assessment them, the Organization Development and Training Office can assure a quality product and continued customer satisfaction.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-13
.... FDA-2011-N-0251] FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities... comment. SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA... controls for facilities provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is...
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ERIC Educational Resources Information Center
Boen, Jennifer
2010-01-01
This study provides two perspectives on the various character traits provided by character education programs by comparing the voices of minority and lower-lower middle class stakeholders with those of upper middle class stakeholders. The literature on the values and virtues based approaches to moral development and character education were…
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Drugs@FDA: FDA Approved Drug Products
... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...
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ERIC Educational Resources Information Center
Tidd, Charlene
2016-01-01
Staff and student surveys at Lane Elementary School (pseudonym) confirm that students lack motivation to complete class work and often struggle to interact appropriately with one another. Similar concerns are reported across the United States as indicated by national Gallup Poll results on student motivation, peer relationships, and feelings of…
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Parr, Alan; Hidalgo, Ismael J; Bode, Chris; Brown, William; Yazdanian, Mehran; Gonzalez, Mario A; Sagawa, Kazuko; Miller, Kevin; Jiang, Wenlei; Stippler, Erika S
2016-01-01
Currently, the FDA allows biowaivers for Class I (high solubility and high permeability) and Class III (high solubility and low permeability) compounds of the Biopharmaceutics Classification System (BCS). Scientific evidence should be provided to support biowaivers for BCS Class I and Class III (high solubility and low permeability) compounds. Data on the effects of excipients on drug permeability are needed to demonstrate that commonly used excipients do not affect the permeability of BCS Class III compounds, which would support the application of biowaivers to Class III compounds. This study was designed to generate such data by assessing the permeability of four BCS Class III compounds and one Class I compound in the presence and absence of five commonly used excipients. The permeability of each of the compounds was assessed, at three to five concentrations, with each excipient in two different models: Caco-2 cell monolayers, and in situ rat intestinal perfusion. No substantial increases in the permeability of any of the compounds were observed in the presence of any of the tested excipients in either of the models, with the exception of disruption of Caco-2 cell monolayer integrity by sodium lauryl sulfate at 0.1 mg/ml and higher. The results suggest that the absorption of these four BCS Class III compounds would not be greatly affected by the tested excipients. This may have implications in supporting biowaivers for BCS Class III compounds in general.
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Friedman, Karen A; Balwan, Sandy; Cacace, Frank; Katona, Kyle; Sunday, Suzanne; Chaudhry, Saima
2014-01-01
As graduate medical education (GME) moves into the Next Accreditation System (NAS), programs must take a critical look at their current models of evaluation and assess how well they align with reporting outcomes. Our objective was to assess the impact on house staff evaluation scores when transitioning from a Dreyfus-based model of evaluation to a Milestone-based model of evaluation. Milestones are a key component of the NAS. We analyzed all end of rotation evaluations of house staff completed by faculty for academic years 2010-2011 (pre-Dreyfus model) and 2011-2012 (post-Milestone model) in one large university-based internal medicine residency training program. Main measures included change in PGY-level average score; slope, range, and separation of average scores across all six Accreditation Council for Graduate Medical Education (ACGME) competencies. Transitioning from a Dreyfus-based model to a Milestone-based model resulted in a larger separation in the scores between our three post-graduate year classes, a steeper progression of scores in the PGY-1 class, a wider use of the 5-point scale on our global end of rotation evaluation form, and a downward shift in the PGY-1 scores and an upward shift in the PGY-3 scores. For faculty trained in both models of assessment, the Milestone-based model had greater discriminatory ability as evidenced by the larger separation in the scores for all the classes, in particular the PGY-1 class.
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Taking the Pulse of the University of Tennessee Medical Center's Health Literacy Knowledge.
Grabeel, Kelsey Leonard; Beeler, Cynthia J
2018-01-01
Low health literacy is well documented in East Tennessee. Before addressing the issue, librarians at the Preston Medical Library, University of Tennessee Medical Center in Knoxville, Tennessee, conducted a needs assessment of hospital staff to determine their knowledge of health literacy and the need for training. As a follow-up, library staff conducted training sessions for nurses through classes, small group meetings, and staff huddles. The result is an increased dialogue of health literacy at the hospital, along with new research projects, a forum, and a summit meeting.
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Wilderjans, T F; Lambrechts, G; Maes, B; Ceulemans, E
2014-11-01
Investigating interdyad (i.e. couples of a client and their usual caregiver) differences in naturally occurring patterns of staff reactions to challenging behaviour (e.g. self-injurious, stereotyped and aggressive/destructive behaviour) of clients with severe or profound intellectual disabilities is important to optimise client-staff interactions. Most studies, however, fail to combine a naturalistic setup with a person-level analysis, in that they do not involve a careful inspection of the interdyad differences and similarities. In this study, the recently proposed Clusterwise Hierarchical Classes Analysis (HICLAS) method is adopted and applied to data of in which video fragments (recorded in a naturalistic setting) of a client showing challenging behaviour and the staff reacting to it were analysed. In a Clusterwise HICLAS analysis, the staff-client dyads are grouped into a number of clusters and the prototypical behaviour-reaction patterns that are specific for each cluster (i.e. interdyad differences and similarities) are revealed. Clusterwise HICLAS discloses clear interdyad differences (and similarities) in the prototypical patterns of clients' challenging behaviour and the associated staff reactions, complementing and qualifying the results of earlier studies in which only general patterns were disclosed. The usefulness and clinical relevance of Clusterwise HICLAS is demonstrated. In particular, Clusterwise HICLAS may capture idiosyncratic aspects of staff-client interactions, which may stimulate direct support workers to adopt person-centred support practices that take the specific abilities of the client into account. © 2013 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-14
...: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' This guidance document describes a means by which low level laser systems for aesthetic use may comply...
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Changing Beliefs about Teaching in Large Undergraduate Mathematics Classes
ERIC Educational Resources Information Center
Kensington-Miller, Barbara; Sneddon, Jamie; Yoon, Caroline; Stewart, Sepideh
2013-01-01
Many lecturers use teacher-centred styles of teaching in large undergraduate mathematics classes, often believing in the effectiveness of such pedagogy. Changing these beliefs about how mathematics should be taught is not a simple process and many academic staff are reluctant to change their ways of lecturing due to tradition and ease. This study…
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Content Area Reading: A Functional Approach.
ERIC Educational Resources Information Center
Plecki, Gerard D.
The implementation of a content reading program at Urbana High School, Urbana, Illinois, is discussed in this document. Reading staff hired with Title VII funds offered assistance to all teachers in the high school by working with classroom teachers in their classes for 60 minutes of class time per week. Free reading time devoted to high-interest…
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ERIC Educational Resources Information Center
King, Samuel O.; Robinson, Carol L.
2009-01-01
University classes in Mathematics are traditionally perceived to be uninspiring and devoid of active student-lecturer communication. Large undergraduate classes further compound the difficulty of engaging students and enabling viable student-lecturer feedback. At the Mathematics Education Centre, Loughborough University, some staff members have…
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Winning Is Everything: The Intersection of Academics and Athletics at Prestige University
ERIC Educational Resources Information Center
Clayton, Ashley B.; Grantham, Ashley; McGurrin, Daniel P.; Paparella, Paul; Pellegrino, Lauren N.
2015-01-01
For years, football and basketball players at Prestige University were earning college credit for classes that never existed. The students were enrolled in fake courses, known as "ghost classes," with no formal instruction or required meeting times and requiring only a single term paper. Faculty, staff, and administrators were complicit…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
...: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability AGENCY: Food and Drug... availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro...
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Improving Wellness on Campus: Service Learning in a Human Nutrition Class
ERIC Educational Resources Information Center
Wood, Bonnie
2003-01-01
In a human nutrition class, students are paired with university faculty or staff volunteer participants. Students teach their service learning partners how to record their food consumption and physical activity during a typical 7-day period. Using these data, students complete nutritional assessments of their partners. (Contains 2 figures.)
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-22
... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [AMS-CN-13-0044] Cotton Classing, Testing..., for an extension and revision to the currently approved information collection entitled Cotton... proposal to: Shethir M. Riva, Chief, Research and Promotion Staff, Cotton and Tobacco Programs, AMS, USDA...
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Hey, I Got Sump'n To Tell You, An' It Cool! A Class for Children with Severe Language Disabilities.
ERIC Educational Resources Information Center
Monaco, Joan L.; Zaslow, Elinor L.
Discussed is an experimental demonstration class for children exhibiting severe language disabilities. Staff includes teacher-therapist, classroom aide, psychologist, audiologist, speech and language pathologists, and occupational therapist. A theoretical framework is provided through discussion of phonological, semantic and syntactic aspects of…
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ERIC Educational Resources Information Center
Rostad, John
1997-01-01
Describes the production of news broadcasts on video by a high school class in Le Center, Minnesota. Topics include software for Apple computers, equipment used, student responsibilities, class curriculum, group work, communication among the production crew, administrative and staff support, and future improvements. (LRW)
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-07
...: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.'' This guidance document describes a means by which contact cooling systems for aesthetic use may comply with the...
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Graduates | Argonne National Laboratory
Staff Directory Argonne National Laboratory Educational Programs Connecting today's world-class research , Argonne is the place to be if you are a graduate student. With access to world-class facilities and world -reknowned researchers, graduate students at Argonne can taste the best of the research and development world
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Beaulieu, Marie-Dominique; Dragieva, Nataliya; Del Grande, Claudio; Dawson, Jeremy; Haggerty, Jeannie L.; Barnsley, Jan; Hogg, William E.; Tousignant, Pierre; West, Michael A.
2014-01-01
Purpose: Evaluate the psychometric properties of the French version of the short 19-item Team Climate Inventory (TCI) and explore the contributions of individual and organizational characteristics to perceived team effectiveness. Method: The TCI was completed by 471 of the 618 (76.2%) healthcare professionals and administrative staff working in a random sample of 37 primary care practices in the province of Quebec. Results: Exploratory factor analysis confirmed the original four-factor model. Cronbach's alphas were excellent (from 0.88 to 0.93). Latent class analysis revealed three-class response structure. Respondents in practices with professional governance had a higher probability of belonging to the “High TCI” class than did practices with community governance (36.7% vs. 19.1%). Administrative staff tended to fall into the “Suboptimal TCI” class more frequently than did physicians (36.5% vs. 19.0%). Conclusion: Results confirm the validity of our French version of the short TCI. The association between professional governance and better team climate merits further exploration. PMID:24726073
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Preclinical Pharmacology and Structure-Activity Studies of Epothilones
NASA Astrophysics Data System (ADS)
Altmann, Karl-Heinz
Microtubule inhibitors are an important class of anticancer agents (1), with clinical applications in the treatment of a variety of cancer types, either as single agents or as part of different combination regimens (2, 3). Microtubule-interacting agents can be grouped into two distinct functional classes, namely, compounds that inhibit the assembly of tubulin heterodimers into microtubule polymers (“tubulin polymerization inhibitors”) and those that stabilize microtubules under normally destabilizing conditions (“microtubule stabilizers”) (4). The latter will also promote the assembly of tubulin heterodimers into microtubule polymers and, as will be discussed later, the induction of tubulin polymerization is often used as a biochemical readout for a quantitative assessment of the interaction of microtubule-stabilizing agents with tubulin. Tubulin polymerization inhibitors such as vincristine and vinblastine have been employed in cancer therapy for more than 40 years (vincristine and vinblastine received FDA approval in 1963 and 1965, respectively). In contrast, the clinical history of microtubule-stabilizing agents is significantly shorter and its beginning dates back no more than 15 years. The first microtubule stabilizer to be introduced into clinical practice was the natural product taxol (paclitaxel; Taxol®) in 1993 (Fig. 1), with FDA approval for the semi-synthetic taxol analog docetaxel (Taxotere®) following three years later. Both compounds rapidly became an important part of today’s armamentarium in the battle against cancer,which marks the emergence of microtubule-stabilizing anti-cancer drugs as an important milestone in the development of modern cancer chemotherapy (5).
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Vlasits, Anna L.; Simon, Julian A.; Raible, David W.; Rubel, Edwin W; Owens, Kelly N.
2012-01-01
Loss of mechanosensory hair cells in the inner ear accounts for many hearing loss and balance disorders. Several beneficial pharmaceutical drugs cause hair cell death as a side effect. These include aminoglycoside antibiotics, such as neomycin, kanamycin and gentamicin, and several cancer chemotherapy drugs, such as cisplatin. Discovering new compounds that protect mammalian hair cells from toxic insults is experimentally difficult because of the inaccessibility of the inner ear. We used the zebrafish lateral line sensory system as an in vivo screening platform to survey a library of FDA-approved pharmaceuticals for compounds that protect hair cells from neomycin, gentamicin, kanamycin and cisplatin. Ten compounds were identified that provide protection from at least two of the four toxins. The resulting compounds fall into several drug classes, including serotonin and dopamine-modulating drugs, adrenergic receptor ligands, and estrogen receptor modulators. The protective compounds show different effects against the different toxins, supporting the idea that each toxin causes hair cell death by distinct, but partially overlapping, mechanisms. Furthermore, some compounds from the same drug classes had different protective properties, suggesting that they might not prevent hair cell death by their known target mechanisms. Some protective compounds blocked gentamicin uptake into hair cells, suggesting that they may block mechanotransduction or other routes of entry. The protective compounds identified in our screen will provide a starting point for studies in mammals as well as further research discovering the cellular signaling pathways that trigger hair cell death. PMID:22967486
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European Science Notes, Volume 40, Number 2.
1986-02-01
authors are primarily ONRL staff members. - Occasionally articles are prepared by or in Cooperation with staff members of the USAF European Office of...development of models; preparation , use, and improvement of ..’ biocatalysts; and animal and plant cell cultures. New Team Examines Acoustic Cavitation...Printing ’ Office, Washington, DC 20402. European Science Note. is a Class I Periodical prepared and distributed by the %, -’ ’ . .:..- Office of Naval
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Newer Antibacterials in Therapy and Clinical Trials
Paknikar, Simi S; Narayana, Sarala
2012-01-01
In order to deal with the rising problem of antibiotic resistance, newer antibacterials are being discovered and added to existing pool. Since the year 2000, however, only four new classes of antibacterials have been discovered. These include the oxazolidinones, glycolipopeptides, glycolipodepepsipeptide and pleuromutilins. Newer drugs were added to existing classes of antibiotics, such as streptogramins, quinolones, beta-lactam antibiotics, and macrolide-, tetracycline- and trimethoprim-related drugs. Most of the antibacterials are directed against resistant S. aureus infections, with very few against resistant gram-negative infections. The following article reviews the antibacterials approved by the FDA after the year 2000 as well as some of those in clinical trials. Data was obtained through a literature search via Pubmed and google as well as a detailed search of our library database. PMID:23181224
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2017-10-20
The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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The discovery of medicines for rare diseases
Swinney, David C; Xia, Shuangluo
2015-01-01
There is a pressing need for new medicines (new molecular entities; NMEs) for rare diseases as few of the 6800 rare diseases (according to the NIH) have approved treatments. Drug discovery strategies for the 102 orphan NMEs approved by the US FDA between 1999 and 2012 were analyzed to learn from past success: 46 NMEs were first in class; 51 were followers; and five were imaging agents. First-in-class medicines were discovered with phenotypic assays (15), target-based approaches (12) and biologic strategies (18). Identification of genetic causes in areas with more basic and translational research such as cancer and in-born errors in metabolism contributed to success regardless of discovery strategy. In conclusion, greater knowledge increases the chance of success and empirical solutions can be effective when knowledge is incomplete. PMID:25068983
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and...: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled...
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Significant differences in pediatric psychotropic side effects: Implications for school performance.
Kubiszyn, Thomas; Mire, Sarah; Dutt, Sonia; Papathopoulos, Katina; Burridge, Andrea Backsheider
2012-03-01
Some side effects (SEs) of increasingly prescribed psychotropic medications can impact student performance in school. SE risk varies, even among drugs from the same class (e.g., antidepressants). Knowing which SEs occur significantly more often than others may enable school psychologists to enhance collaborative risk-benefit analysis, medication monitoring, data-based decision-making, and inform mitigation efforts. SE data from Full Prescribing Information (PI) on the FDA website for ADHD drugs, atypical antipsychotics, and antidepressants with pediatric indications were analyzed. Risk ratios (RR) are reported for each drug within a category compared with placebo. RR tables and graphs inform the reader about SE incidence differences for each drug and provide clear evidence of the wide variability in SE incidence in the FDA data. Breslow-Day and Cochran Mantel-Haenszel methods were used to test for drug-placebo SE differences and to test for significance across drugs within each category based on odds ratios (ORs). Significant drug-placebo differences were found for each drug compared with placebo, when odds were pooled across all drugs in a category compared with placebo, and between some drugs within categories. Unexpectedly, many large RR differences did not reach significance. Potential explanations are offered, including limitations of the FDA data sets and statistical and methodological issues. Future research directions are offered. The potential impact of certain SEs on school performance, mitigation strategies, and the potential role of the school psychologist is discussed, with consideration for ethical and legal limitations. (c) 2012 APA, all rights reserved.
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Development Considerations for Nanocrystal Drug Products.
Chen, Mei-Ling; John, Mathew; Lee, Sau L; Tyner, Katherine M
2017-05-01
Nanocrystal technology has emerged as a valuable tool for facilitating the delivery of poorly water-soluble active pharmaceutical ingredients (APIs) and enhancing API bioavailability. To date, the US Food and Drug Administration (FDA) has received over 80 applications for drug products containing nanocrystals. These products can be delivered by different routes of administration and are used in a variety of therapeutic areas. To aid in identifying key developmental considerations for these products, a retrospective analysis was performed on the submissions received by the FDA to date. Over 60% of the submissions were for the oral route of administration. Based on the Biopharmaceutics Classification System (BCS), most nanocrystal drugs submitted to the FDA are class II compounds that possess low aqueous solubility and high intestinal permeability. Impact of food on drug bioavailability was reduced for most nanocrystal formulations as compared with their micronized counterparts. For all routes of administration, dose proportionality was observed for some, but not all, nanocrystal products. Particular emphasis in the development of nanocrystal products was placed on the in-process tests and controls at critical manufacturing steps (such as milling process), mitigation and control of process-related impurities, and the stability of APIs or polymorphic form (s) during manufacturing and upon storage. This emphasis resulted in identifying challenges to the development of these products including accurate determination of particle size (distribution) of drug substance and/or nanocrystal colloidal dispersion, identification of polymorphic form (s), and establishment of drug substance/product specifications.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-07
..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability...\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc.... Trabecular Micro- Bypass Stent and Inserter. P110007, FDA-2012-M-0734....... Abbott Medical Healon[supreg...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and... information. SUMMARY: In September 2011, the Food and Drug Administration (FDA or the Agency) asked the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-08
... infarction, treatment of in-stent restenosis and/or post-deployment stent expansion. Cutting/scoring PTCA... of in-stent restenosis and/or post- deployment stent expansion, be reclassified from class III to... PTCA catheters for the treatment of in-stent restenosis and/or post-deployment stent expansion, but not...
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ERIC Educational Resources Information Center
Stanger-Hall, Kathrin F.; Lang, Sarah; Maas, Martha
2010-01-01
We tested the effect of voluntary peer-facilitated study groups on student learning in large introductory biology lecture classes. The peer facilitators (preceptors) were trained as part of a Teaching Team (faculty, graduate assistants, and preceptors) by faculty and Learning Center staff. Each preceptor offered one weekly study group to all…
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Teaching the Art of Employee Discipline to Educational Leadership Candidates
ERIC Educational Resources Information Center
Hewitt, Paul
2011-01-01
This activity is designed to be utilized in a School Law class, but is also appropriate for a class in Human Resources. Holding students and staff accountable for their actions is essential to a well run school. School principals are prepared to deal with student accountability and student discipline issues, but rarely are principals ready to deal…
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ERIC Educational Resources Information Center
Keddie, Amanda
2015-01-01
This article explores the politically contentious issue of White working-class student under-achievement within one particular school--a large and culturally diverse comprehensive secondary school in the greater London area. The article examines the equity philosophies and identity politics articulated by staff in their understanding of and…
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Consent Form Return Rates for Third-Grade Urban Elementary Students
ERIC Educational Resources Information Center
Ji, Peter; Flay, Brian R.; Phil, D.; DuBois, David L.; Brechling, Vanessa; Day, Joseph; Cantillon, Dan
2006-01-01
Objective: To maximize active parent consent form return rates for third-grade minority, urban students enrolled in predominantly low-income elementary schools in Chicago, Ill. Methods: Research staff used a class incentive and class visits to retrieve consent forms from students. Results: Of the 811 third-grade students, 98% returned a form and …
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Gender-Based Education: Why It Works at the Middle School Level.
ERIC Educational Resources Information Center
Perry, William C.
1996-01-01
To counter gender bias effects and improve student learning, staff at a Virginia middle school decided to group eighth-grade students by gender for math and science instruction. Girls felt freer to speak out. Grade point averages in gender-based science and math classes for both girls and boys were higher than in coeducational classes. (MLH)
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Extending the Principles of Intensive Writing to Large Macroeconomics Classes
ERIC Educational Resources Information Center
Docherty, Peter; Tse, Harry; Forman, Ross; McKenzie, Jo
2010-01-01
The authors report on the design and implementation of a pilot program to extend the principles of intensive writing outlined by W. Lee Hansen (1998), Murray S. Simpson and Shireen E. Carroll (1999) and David Carless (2006) to large macroeconomics classes. The key aspect of this program was its collaborative nature, with staff from two specialist…
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Fire Resistance Testing of Bulkhead and Deck Penetrations.
1985-10-01
consisted of a steel plate identical to that used in the Class A-0 assembly, but rockwool insulation was applied to the fire side of the steel plate and...penetration samples were then insulated with rockwool batts to form a Class A-60 assembly (Figure 2). Between nine and twenty-eight temperature readings...representative of Class A-O construction. The UL staff secured insulation ( rockwool batts) to the fire side of the steel plates and penetrating items to prepare
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Friedman, Karen A; Balwan, Sandy; Cacace, Frank; Katona, Kyle; Sunday, Suzanne; Chaudhry, Saima
2014-01-01
Purpose As graduate medical education (GME) moves into the Next Accreditation System (NAS), programs must take a critical look at their current models of evaluation and assess how well they align with reporting outcomes. Our objective was to assess the impact on house staff evaluation scores when transitioning from a Dreyfus-based model of evaluation to a Milestone-based model of evaluation. Milestones are a key component of the NAS. Method We analyzed all end of rotation evaluations of house staff completed by faculty for academic years 2010-2011 (pre-Dreyfus model) and 2011-2012 (post-Milestone model) in one large university-based internal medicine residency training program. Main measures included change in PGY-level average score; slope, range, and separation of average scores across all six Accreditation Council for Graduate Medical Education (ACGME) competencies. Results Transitioning from a Dreyfus-based model to a Milestone-based model resulted in a larger separation in the scores between our three post-graduate year classes, a steeper progression of scores in the PGY-1 class, a wider use of the 5-point scale on our global end of rotation evaluation form, and a downward shift in the PGY-1 scores and an upward shift in the PGY-3 scores. Conclusions For faculty trained in both models of assessment, the Milestone-based model had greater discriminatory ability as evidenced by the larger separation in the scores for all the classes, in particular the PGY-1 class.
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Oncolytic viruses: a new class of immunotherapy drugs.
Kaufman, Howard L; Kohlhapp, Frederick J; Zloza, Andrew
2015-09-01
Oncolytic viruses represent a new class of therapeutic agents that promote anti-tumour responses through a dual mechanism of action that is dependent on selective tumour cell killing and the induction of systemic anti-tumour immunity. The molecular and cellular mechanisms of action are not fully elucidated but are likely to depend on viral replication within transformed cells, induction of primary cell death, interaction with tumour cell antiviral elements and initiation of innate and adaptive anti-tumour immunity. A variety of native and genetically modified viruses have been developed as oncolytic agents, and the approval of the first oncolytic virus by the US Food and Drug Administration (FDA) is anticipated in the near future. This Review provides a comprehensive overview of the basic biology supporting oncolytic viruses as cancer therapeutic agents, describes oncolytic viruses in advanced clinical trials and discusses the unique challenges in the development of oncolytic viruses as a new class of drugs for the treatment of cancer.
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Perceptions of the Food and Drug Administration as a Tobacco Regulator
Jarman, Kristen L.; Ranney, Leah M.; Baker, Hannah M.; Vallejos, Quirina M.; Goldstein, Adam O.
2017-01-01
Objectives The U. S. Food and Drug Administration (FDA) now has regulatory authority over all tobacco products. Little is known about public awareness and perceptions of FDA in their new role as a tobacco regulator. This research utilizes focus groups to examine perceptions of FDA as a tobacco regulator so that FDA can better communicate with the public about this role. Methods We conducted 6 focus groups in 2014 among a diverse sample of smokers and non-smokers. Participants were asked if they had heard of FDA, what they knew about FDA, if they associated FDA with tobacco, and their thoughts about this FDA role. Results A total of 41 individuals participated. Although nearly all participants had heard of FDA, most were not aware of FDA’s regulatory authority over tobacco products, did not associate the role of FDA with tobacco, and some drew comparisons between FDA’s work in tobacco and their work regulating food and drugs. Conclusion Data suggest that although public awareness of FDA regulatory authority over tobacco is low, with proper public education, the public may find FDA to be a trustworthy source of tobacco regulation. PMID:29051917
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2009-06-01
management of a former Navy- owned warehouse in Bahrain. “Today when folks in Bahrain requisition material from Kuwait, we y Army Staff Sgt. Thomas ...members who staff each section who provide the key in- gredient for sustaining world-class war ghter support. Navy Capt . Michelle Skubic, director...weapon systems. 23Loglines May - June 2009 Roberto Arenas and Ron Gay , tools and parts attendants at Defense Logistics Agency Cherry Point, N.C
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Wang, Fang; Li, Wei; Li, Rong; Tan, Guolin; Luo, Dan
2016-05-01
To investigate the situation regarding the cleaning and sterilization of endonasal endoscopes in department of otolaryngology in Hunan Province, and to provide strategy for improving the level of sterilization and management of endonasal endoscopes. A total of 100 medical institutions were investigated by spot assessment, check and sampling. Data was analyzed by multivariate analysis. The qualified rate of rules and regulations for endoscopy was 28.8% in the second-class hospitals and 45% in the top-class hospitals. The qualified rate of environment for endoscopy cleaning and sterilization was 36.3% in the second-class hospitals and 85% in the top-class hospitals. The main problems include lack of independent disinfection room, the space not large enough, and/or lack of ventilation system. The qualified rate of bacterial detection for post-sterilized endoscopes and biopsy forceps was 93.8% in the second-class hospitals and 95.0% in the top-class hospitals, and the main pathogenic bacteria was gram-positive cocci and gram-negative bacilli. The multivariate analysis showed that the influencial factors for endoscope cleaning and disinfection are as follows: staffs responsible for the cleaning and sterilization of otolaryngology endoscopes, the standard for cleaning and disinfection process, and the frequency of endoscope use. The present situation of cleaning and sterilization for otolaryngology endoscopes is better in the top-class hospitals than that in the second-class hospitals. The sterilization and management of otolaryngology endoscopy are needed to be improved, and the staff training is needed, especially in the primary hospitals.
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Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co‐encapsulation
Peloquin, C; Santillo, F; Haubrich, R; Muttera, L; Moser, K; Savage, GM; Benson, CA; Blaschke, TF
2017-01-01
High‐resolution measurement of medication adherence is essential to personalized drug therapy. A US Food and Drug Administration (FDA)‐cleared device, using an edible ingestion sensor (IS), external wearable patch, and paired mobile device can detect and record ingestion events. Oral medications must be combined with an IS to generate precise “digitized‐medication” ingestion records. We developed a Good Manufacturing Practice protocol to repackage oral medications with the IS within certified Capsugel capsules, termed co‐encapsulation (CoE). A randomized bioequivalence study of CoE‐IS‐Rifamate (Isoniazid/Rifampin 150/300 mg) vs. native‐Rifamate was conducted in 12 patients with active Mycobacterium tuberculosis and demonstrated bioequivalence using the population method ratio test (95% confidence interval). Subsequently, CoE‐IS‐medications across all biopharmaceutical classes underwent in vitro dissolution testing utilizing USP and FDA guidelines. CoE‐IS medications tested met USP dissolution specifications and were equivalent to their native formulations. CoE combines oral medications with the IS without altering the quality of the native formulation, generating “digitized” medications for remote capture of dosing histories. PMID:28597911
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2009-05-01
class medical facility. Based on a review of relevant reports and other literature, the HSAS’s collective experience and judgment, and extensive...analyses of the demand for PACU services and of the experience and skills of PACU staff relative to the skills needed to properly care for other...class medical facility. Based on a review of relevant reports and other literature, the Subcommittee’s collective experience and judgment, and
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Patterns and predictors of violence against children in Uganda: a latent class analysis
Clarke, Kelly; Patalay, Praveetha; Allen, Elizabeth; Knight, Louise; Naker, Dipak; Devries, Karen
2016-01-01
Objective To explore patterns of physical, emotional and sexual violence against Ugandan children. Design Latent class and multinomial logistic regression analysis of cross-sectional data. Setting Luwero District, Uganda. Participants In all, 3706 primary 5, 6 and 7 students attending 42 primary schools. Main outcome and measure To measure violence, we used the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool—Child Institutional. We used the Strengths and Difficulties Questionnaire to assess mental health and administered reading, spelling and maths tests. Results We identified three violence classes. Class 1 (N=696 18.8%) was characterised by emotional and physical violence by parents and relatives, and sexual and emotional abuse by boyfriends, girlfriends and unrelated adults outside school. Class 2 (N=975 26.3%) was characterised by physical, emotional and sexual violence by peers (male and female students). Children in Classes 1 and 2 also had a high probability of exposure to emotional and physical violence by school staff. Class 3 (N=2035 54.9%) was characterised by physical violence by school staff and a lower probability of all other forms of violence compared to Classes 1 and 2. Children in Classes 1 and 2 were more likely to have worked for money (Class 1 Relative Risk Ratio 1.97, 95% CI 1.54 to 2.51; Class 2 1.55, 1.29 to 1.86), been absent from school in the previous week (Class 1 1.31, 1.02 to 1.67; Class 2 1.34, 1.10 to 1.63) and to have more mental health difficulties (Class 1 1.09, 1.07 to 1.11; Class 2 1.11, 1.09 to 1.13) compared to children in Class 3. Female sex (3.44, 2.48 to 4.78) and number of children sharing a sleeping area predicted being in Class 1. Conclusions Childhood violence in Uganda forms distinct patterns, clustered by perpetrator and setting. Research is needed to understand experiences of victimised children, and to develop mental health interventions for those with severe violence exposures. Trial registration number NCT01678846; Results. PMID:27221125
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ERIC Educational Resources Information Center
Fobbs, Timothy J.
2015-01-01
Students who register for classes late have always been a challenge for community colleges. The student who registers late creates a burden on the enrollment staff, and they create academic achievement challenges for themselves as well. Late class registration has been linked to lower overall GPA's, and to overall lower academic performance. This…
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ERIC Educational Resources Information Center
Omer, Selma; Hickson, Gilles; Tache, Stephanie; Blind, Raymond; Masters, Susan; Loeser, Helen; Souza, Kevin; Mkony, Charles; Debas, Haile; O'Sullivan, Patricia
2008-01-01
Teaching to large classes is often challenging particularly when the faculty and teaching resources are limited. Innovative, less staff intensive ways need to be explored to enhance teaching and to engage students. We describe our experience teaching biochemistry to 350 students at Muhimbili University of Health and Allied Sciences (MUHAS) under…
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ERIC Educational Resources Information Center
Heng, Tang T.
2014-01-01
While the parental involvement field has progressed from asking what the impact of parental involvement is to how we can better involve parents, research has lagged in finding out how sociocultural and class differentials between homes and schools affect immigrant families' interactions with schools. This case study uses ethnographic tools to…
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ERIC Educational Resources Information Center
Morrison, Andrew
2010-01-01
Using data from in-depth individual interviews, this article discusses the educational experiences and ambitions of two young working-class full-time female students. The two studies are derived from a wider investigation into student post-16 educational experiences and decision-making, based on a sample of students and staff of an Advanced…
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ERIC Educational Resources Information Center
Maringe, Felix; Sing, Nevensha
2014-01-01
Marketisation, increased student mobility, the massification of Higher Education (HE) and stagnating staff numbers in universities have combined to cause a ripple effect of change both in the demography and size of university classes across the world. This has implications for the quality and equity of learning and the need to examine and to…
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Connor, Michael J.; University of California Irvine School of Medicine, Irvine, California; Tringale, Kathryn
Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Resultsmore » for RODs were compared with those for other devices by Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.« less
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The nature and pattern of coronary stent recalls.
Kumar, Sanjay; Innasimuthu, Antony L; Marmur, Jonathan D
2014-09-01
Each year, over 1 million percutaneous coronary interventions (PCIs) are performed in the United States. Coronary stents have been shown to reduce restenosis or abrupt vessel closure and therefore have improved the success of PCI. Rarely, manufacturers recall stents due to unanticipated problems. We sought to study the extent and pattern of stent recall. To determine the number and rate of stent recall and safety alerts, to identify trends in the rates, and to identify the nature of stent recalls. The Food and Drug Administration (FDA; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm) and Healthcare Recall Management websites (RASMAS; https://alerts.rasmas.noblis.org/rasmas/c/selectViewAlertList.do) were searched. The search terms for recall were, "coronary stent" or "stent." Dates were searched between November 2002 and June 2013. There were 17 coronary stent recalls involving almost 500,000 units; 12 recalls (71%) were before 2006 and 5 recalls (29%) were after. Thirteen recalls (76%) consisted of class II recalls (moderate hazard); the remaining 4 were equally split between class I (severe hazard) and class III (mild hazard; 12% each). The common reasons for recall were concerns with sterility (29%) followed by wrong labeling/packaging (23%) and impaired delivery of stent (18%). In terms of units involved with recalls, 98% (472,189/481,131) were related to wrong labeling/ packaging or misbranding, while 0.1% (542/481,131) were related to potential for broken struts or crack in inflation port hub or sterility. However, approximately 2% of units were related to the potentially lethal problem of impaired balloon inflation. Recalls involved multiple manufacturers with various stent types. The overall incidence of coronary stent recall is low and has declined over the years. The majority of stent recalls are of moderate hazard. However, due to the possibility of serious injury, clinicians should be aware of recalls.
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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... and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical ... æ¥æ¬èª | ÙØ§Ø±Ø³Û | English FDA Accessibility Careers FDA Basics FOIA No FEAR Act ...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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36 CFR 13.980 - Other FDA closures and restrictions.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Other FDA closures and... Preserve Frontcountry Developed Area (fda) § 13.980 Other FDA closures and restrictions. The Superintendent may prohibit or otherwise restrict activities in the FDA to protect public health, safety, or park...
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21 CFR 314.102 - Communications between FDA and applicants.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Communications between FDA and applicants. 314.102... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.102 Communications between FDA and applicants. (a) General...
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78 FR 18233 - Medical Devices; Technical Amendment
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-26
... the right column: Section Remove Add 814.20 http://www.fda.gov/ http://www.fda.gov/ cdrh/devadvice.../ PremarketApproval PMA/default.htm. 822.7 http://www.fda.gov/ http://www.fda.gov/ cdrh/ombudsman/ AboutFDA/ dispute.html. CentersOffices/ OfficeofMedicalPr oductsandTobacco/ CDRH/ CDRHOmbudsman/ default.htm. 822.15...
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HCPCS Coding: An Integral Part of Your Reimbursement Strategy.
Nusgart, Marcia
2013-12-01
The first step to a successful reimbursement strategy is to ensure that your wound care product has the most appropriate Healthcare Common Procedure Coding System (HCPCS) code (or billing) for your product. The correct HCPCS code plays an essential role in patient access to new and existing technologies. When devising a strategy to obtain a HCPCS code for its product, companies must consider a number of factors as follows: (1) Has the product gone through the Food and Drug Administration (FDA) regulatory process or does it need to do so? Will the FDA code designation impact which HCPCS code will be assigned to your product? (2) In what "site of service" do you intend to market your product? Where will your customers use the product? Which coding system (CPT ® or HCPCS) applies to your product? (3) Does a HCPCS code for a similar product already exist? Does your product fit under the existing HCPCS code? (4) Does your product need a new HCPCS code? What is the linkage, if any, between coding, payment, and coverage for the product? Researchers and companies need to start early and place the same emphasis on a reimbursement strategy as it does on a regulatory strategy. Your reimbursement strategy staff should be involved early in the process, preferably during product research and development and clinical trial discussions.
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Communication in Assisted Living*
Williams, Kristine N.; Warren, Carol A.B.
2009-01-01
This study of communication in an Assisted Living Facility (ALF) focuses on staff’s interpretive frameworks and situational tactics for managing elderly residents. It is based on interviews with staff and residents in an ALF together with ethnographic fieldwork. As in other quasi-total institutions, staff members engage in control as well as care, monitoring residents for compliance with rules and directives. Residents, aware of the threat of being moved to a nursing home, also monitor their own behavior and cognition in comparison to other residents. Other communication issues include the infantilization of the elderly by staff, and the race, class, and ethnic prejudices of residents. PMID:20107612
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21 CFR 1.280 - How must you submit prior notice?
Code of Federal Regulations, 2010 CFR
2010-04-01
... to FDA. You must submit all prior notice information in the English language, except that an... Commercial System (ABI/ACS); or (2) The FDA PNSI at http://www.access.fda.gov. You must submit prior notice through the FDA Prior Notice System Interface (FDA PNSI) for articles of food imported or offered for...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-31
... Safety Testing of Sunlamp Products'' Form FDA 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' Form FDA 3633''General Variance Request'' Form FDA 3634 ``Television Products Annual Report'' Form FDA 3635 ``Laser Light Show Notification'' Form FDA 3636 ``Guide for Preparing...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-12
... Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products'' FDA Form 3637...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-13
... of Sunlamps and Sunlamp Products'' FDA Form 3632 ``Guide for Preparing Product Reports on Lasers and Products Containing Lasers'' FDA Form 3633 ``General Variance Request'' FDA Form 3634 ``Television Products Annual Report'' FDA Form 3635 ``Laser Light Show Notification'' FDA Form 3636 ``Guide for Preparing...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2012 CFR
2012-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2013 CFR
2013-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 42 Public Health 2 2014-10-01 2014-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2010 CFR
2010-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 42 Public Health 2 2013-10-01 2013-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2011 CFR
2011-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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21 CFR 314.106 - Foreign data.
Code of Federal Regulations, 2014 CFR
2014-04-01
... USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated... without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA is able to validate the data through an on-site inspection or other appropriate means. Failure of...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 42 Public Health 2 2011-10-01 2011-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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42 CFR 405.203 - FDA categorization of investigational devices.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 42 Public Health 2 2012-10-01 2012-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational devices. (a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Experimental...
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21 CFR 830.100 - FDA accreditation of an issuing agency.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA accreditation of an issuing agency. 830.100... (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA Accreditation of an Issuing Agency § 830.100 FDA... issuing agency. (b) Accreditation criteria. FDA may accredit an organization as an issuing agency, if the...
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Cuypers, J; Mathieu, C; Benhalima, K
2013-01-01
Treatment of type 2 diabetes (T2DM) continues to present challenges, with significant proportion of patients failing to achieve and maintain glycemic targets. Despite the availability of many oral antidiabetic agents, therapeutic efficacy is offset by side effects such as weight gain and hypoglycemia. Therefore, the search for novel therapeutic agents with an improved benefit-risk profile continues. Recent research has focused on the kidney as a potential therapeutic target, especially because maximal renal glucose reabsorption is increased in T2DM. Under normal physiological conditions, nearly all filtered glucose is reabsorbed in the proximal tubule of the nephron, principally via the sodium-glucose cotransporter 2 (SGLT2). SGLT2-inhibitors are a new class of oral antidiabetics, which reduce hyperglycemia by increasing urinary glucose excretion independently of insulin secretion or action. Clinical results are promising with significant lowering of HbA1c without increased risk of hypoglycemia, reduction of body weight and reduction of systolic blood pressure. Dapagliflozin is the first highly selective SGLT2-inhibitor approved by the European Medecine Agency. Canagliflozin and empagliflozin are undergoing phase III trials. Actual safety issues are an increased risk for genital- and urinary tract infections and a possible increased risk for bladder and breast cancer. This led to refusal of dapagliflozin by the Food and Drug Administration (FDA). A large randomized control trial is therefore warranted by the FDA. This review provides an overview of the current evidence available so far on the therapeutic potential of the SGLT2-inhibitors for the treatment of T2DM.
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Wilson, Daniel J; Schutte, Scott M; Abel, Steven R
2015-06-01
To review the commercially available ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs), identify opportunities for therapeutic substitutions within and outside of their Food and Drug Administration (FDA)-approved indications, and identify clinically superior drugs within the class for specific indications. A PubMed search (1992 through January 2014) was performed on the terms diclofenac, ketorolac, flurbiprofen, bromfenac, and nepafenac. Clinical trials, meta-analyses, and review articles were evaluated if they were written in English and pertained to human subjects. Studies were excluded if they were in vitro studies, solely evaluated pharmacokinetic or pharmacodynamic properties, did not relate to the topical ophthalmic route, did not evaluate the FDA-approved indications of any available ophthalmic NSAID, or compared a reviewed drug with a nonreviewed drug (without placebo comparison). A total of 67 articles met the criteria for evaluation. Article quality, study design, and dosing of the medications were assessed to determine the clinical applicability of the results. The quality of the article was determined using the Oxford Centre for Evidence-based Medicine Levels of Evidence 1. Many formulations of the 5 reviewed NSAIDs have been studied across the 4 primary indications. These indications are (1) pain and inflammation associated with cataract surgery, (2) pain associated with corneal refractive surgery, (3) inhibition of intraoperative miosis, and (4) seasonal allergic conjunctivitis. Several studies have directly compared drugs within this class and have identified instances in which certain selections are therapeutically superior or equivalent to another. This information provides practitioners with guidance in selecting an optimal medication. © The Author(s) 2015.
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Stavchansky, Salomon
2008-06-01
Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA-BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility-Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting step in the absorption of Class 3 drugs is the permeability through the intestinal membrane. This commentary will focus its attention on the scientific considerations which need to be examined to assess the risk and the benefit prior to granting a waiver of in vivo bioavailability and/or bioequivalence studies for Class 3 drugs. It will examine the forces affecting the interconnectivity of the neuronal, immunological and hormonal systems in the gastrointestinal tract that may affect its permeability and functionality. It will also challenge the assumption that in vitro dissolution and in vitro permeability studies in tissue cultures in the presence and absence of excipients are good predictors for in vivo dissolution and in vivo permeability which are at the heart of the BCS.
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Pollock, A M; Whitty, P M
1990-01-01
An investigation into an outbreak of food poisoning caused by Clostridium perfringens showed evidence of poor food handling by catering staff. The reasons behind this were explored by interviewing catering staff, analysing shifts and rotas, and looking at staff vacancies. Morale was low because of staff shortages resulting from a long term recruitment problem. In consequence staff were working double shifts and often for weeks on end without a day off. The reasons for the recruitment problem included the difficulty of recruiting semiskilled labour from a middle class area, low wages, lack of management support, and the poor image of the hospital as a place of work. Similar factors affect the recruitment and retention of ancillary staff nationally. The NHS has a poor record as an employer of ancillary staff, paying lower wages than other organisations for equivalent posts. Competitive tendering has further worsened the position of ancillary staff, with the result that good quality of care and service has often not been achieved. The NHS Review, with its emphasis on quality of care, makes no mention of ancillary staff. Yet high standards of ancillary provision are essential if further outbreaks of food poisoning in hospitals are to be prevented. PMID:2106996
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Pollock, A M; Whitty, P M
1990-02-10
An investigation into an outbreak of food poisoning caused by Clostridium perfringens showed evidence of poor food handling by catering staff. The reasons behind this were explored by interviewing catering staff, analysing shifts and rotas, and looking at staff vacancies. Morale was low because of staff shortages resulting from a long term recruitment problem. In consequence staff were working double shifts and often for weeks on end without a day off. The reasons for the recruitment problem included the difficulty of recruiting semiskilled labour from a middle class area, low wages, lack of management support, and the poor image of the hospital as a place of work. Similar factors affect the recruitment and retention of ancillary staff nationally. The NHS has a poor record as an employer of ancillary staff, paying lower wages than other organisations for equivalent posts. Competitive tendering has further worsened the position of ancillary staff, with the result that good quality of care and service has often not been achieved. The NHS Review, with its emphasis on quality of care, makes no mention of ancillary staff. Yet high standards of ancillary provision are essential if further outbreaks of food poisoning in hospitals are to be prevented.
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0253] Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research Misconduct... Drug Administration's (FDA's) regulations for the protection of privacy, FDA is publishing notice of a...
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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21 CFR 60.34 - FDA action on petitions.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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21 CFR 60.34 - FDA action on petitions.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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21 CFR 60.34 - FDA action on petitions.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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21 CFR 60.34 - FDA action on petitions.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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21 CFR 14.15 - Committees working under a contract with FDA.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Committees working under a contract with FDA. 14... under a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical... contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory...
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21 CFR 830.220 - Termination of FDA service as an issuing agency.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Termination of FDA service as an issuing agency... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA as an Issuing Agency § 830.220 Termination of FDA service as an issuing agency. (a) FDA may end our services as an issuing agency if we...
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21 CFR 60.34 - FDA action on petitions.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA action on petitions. 60.34 Section 60.34 Food... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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ERIC Educational Resources Information Center
Mirza, Heidi Safia; Meetoo, Veena
2018-01-01
This article draws on an analysis of the narratives of teachers, policy-makers and young Muslim working-class women to explore how schools worked towards producing the model neoliberal middle-class female student. In two urban case-study schools, teaching staff encouraged the girls to actively challenge their culture through discourses grounded in…
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Making Politics Palatable: Using Television Drama in High School Civics and Government Classes
ERIC Educational Resources Information Center
Journell, Wayne; Buchanan, Lisa Brown
2012-01-01
The authors make a case for using "The West Wing," a political drama that aired on NBC from 1999 to 2006, as an instructional tool in high school civics and government classes. The show offers a realistic portrayal of life in the White House through the eyes of Democratic President Josiah Bartlet and his senior staff that can further students'…
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Redox Biology Course Registration Form | Center for Cancer Research
The Redox Biology class is open to all NIH/NCI fellows and staff and will be held Septhember 27 - November 8, 2016. The last day to register is: September 21, 2016. The first 100 registrants will be accepted for the class. Those who plan to participate by Video TeleConference should also register so that you can receive the speaker handouts in advance.
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FDA Warns About Stem Cell Therapies
... For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...
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Dietary supplements: What's in a name? What's in the bottle?
Marcus, Donald M
2016-01-01
The Dietary Supplement Health and Education Act of 1994 (DSHEA), which arbitrarily classified herbals and other medicinal products as dietary supplements, obscured fundamental differences between two classes of products. Authentic supplements to the diet, such as multivitamins or calcium, have nutritional value and are safe. Herbals are used worldwide as medicines, they do not supplement the diet, they may cause severe adverse events, and they should be regulated as medicines. DSHEA also prevented the Food and Drug Administration (FDA) from effectively regulating herbal supplements as medicines. One consequence of weak FDA regulatory oversight is the poor quality of herbals. FDA inspections of manufacturing facilities have revealed violations of good manufacturing practices in over half of facilities inspected, including unsanitary conditions and lack of product specifications. Moreover, many "all natural" herbals marketed for weight loss, enhancement of sexual health and improving sports performance are adulterated with prescription and over-the-counter medications that have caused adverse cardiovascular events. New procedures to authenticate the identity of plants used in herbals will neither detect adulteration by medications nor provide assurance of appropriate pharmacological activity or safety. Nonvitamin, nonmineral "supplements" should be regulated as medicines, but revision or repeal of DSHEA faces strong opposition in Congress. The marketing of botanical supplements is based on unfounded claims that they are safe and effective. Health professionals need to inform patients and the public that there is no reason to take herbal medicines whose composition and benefits are unknown, and whose risks are evident. Copyright © 2015 John Wiley & Sons, Ltd.
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Abuse Liability Assessment of Tobacco Products Including Potential Reduced Exposure Products (PREPs)
Carter, Lawrence P.; Stitzer, Maxine L.; Henningfield, Jack E.; O'Connor, Rich J.; Cummings, K. Michael; Hatsukami, Dorothy K.
2009-01-01
The harm produced by tobacco products is a result of frequent use of a highly toxic product. Reducing the adverse public health impact of tobacco products might be most effectively achieved by reducing the likelihood of their use and the toxicity of the products. Products that retain some characteristics of cigarettes, but have been altered with the intention of reducing toxicity have been referred to as modified risk tobacco products or potential reduced exposure products (MRTP/PREPS). Evaluation of their content, emission, and toxicity is discussed in other articles in this special issue. Here, we discuss the methodology that has been used to examine the likelihood of abuse or addiction. Abuse liability assessment (ALA) methodology has been used by the Food and Drug Administration (FDA) and other drug regulatory agencies world-wide for decades to assess the risks posed by a wide variety of pharmacologically active substances. ALA is routinely required among other evaluations of safety during the premarket assessment of new drugs, and is continually adapted to meet the challenges posed by new drug classes and drug formulations. In the 2009 law giving FDA regulation over tobacco products, FDA is now required to evaluate new tobacco products including MRTP/PREPs to determine their risk for abuse and toxicity at the population level. This paper describes the traditional tools and methods of ALA that can be used to evaluate new tobacco and nicotine products including MRTP/PREPs. Such ALA data could contribute to the scientific foundation on which future public policy decisions are based. PMID:19959676
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Abuse liability assessment of tobacco products including potential reduced exposure products.
Carter, Lawrence P; Stitzer, Maxine L; Henningfield, Jack E; O'Connor, Rich J; Cummings, K Michael; Hatsukami, Dorothy K
2009-12-01
The harm produced by tobacco products is a result of frequent use of a highly toxic product. Reducing the adverse public health impact of tobacco products might be most effectively achieved by reducing the likelihood of their use and the toxicity of the products. Products that retain some characteristics of cigarettes but have been altered with the intention of reducing toxicity have been referred to as modified risk tobacco products or potential reduced exposure products (MRTP/PREP). Evaluation of their content, emission, and toxicity is discussed in other articles in this special issue. Here, we discuss the methodology that has been used to examine the likelihood of abuse or addiction. Abuse liability assessment (ALA) methodology has been used by the Food and Drug Administration (FDA) and other drug regulatory agencies world-wide for decades to assess the risks posed by a wide variety of pharmacologically active substances. ALA is routinely required among other evaluations of safety during the pre-market assessment of new drugs, and is continually adapted to meet the challenges posed by new drug classes and drug formulations. In the 2009 law giving FDA regulation over tobacco products, FDA is now required to evaluate new tobacco products including MRTP/PREPs to determine their risk for abuse and toxicity at the population level. This article describes the traditional tools and methods of ALA that can be used to evaluate new tobacco and nicotine products including MRTP/PREPs. Such ALA data could contribute to the scientific foundation on which future public policy decisions are based.
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1995-07-01
spectabilis Royal fern C FDA n/o Remirea maritima Beach star E FDA, FNAI o Scaevola plumeria Scaevola T FDA o Tillandsia simulata Wildpine; air plant...unnamed) T FDA n/o Tillandsia utriculata Giant wildpine; giant air plant C FDA o 1 E = Endangered; T = Threatened; T(S/A) = Threatened due to
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21 CFR 1.393 - What information must FDA include in the detention order?
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...
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21 CFR 1.393 - What information must FDA include in the detention order?
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...
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Code of Federal Regulations, 2014 CFR
2014-10-01
... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare Department... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...
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Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...
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21 CFR 1.393 - What information must FDA include in the detention order?
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...
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21 CFR 830.210 - Eligibility for use of FDA as an issuing agency.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Eligibility for use of FDA as an issuing agency... SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION FDA as an Issuing Agency § 830.210 Eligibility for use of FDA as an issuing agency. When FDA acts as an issuing agency, any labeler will be...
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Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...
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Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...
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Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...
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Code of Federal Regulations, 2013 CFR
2013-10-01
... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...
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Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false What expedited procedures apply when FDA initiates... procedures apply when FDA initiates a seizure action against a detained perishable food? If FDA initiates a... under this subpart, FDA will send the seizure recommendation to the Department of Justice (DOJ) within 4...
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21 CFR 1.393 - What information must FDA include in the detention order?
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...
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Code of Federal Regulations, 2012 CFR
2012-10-01
... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...
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Code of Federal Regulations, 2010 CFR
2010-10-01
... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...
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Code of Federal Regulations, 2011 CFR
2011-10-01
... with organizations subject to FDA regulation. 73a.735-201 Section 73a.735-201 Public Welfare DEPARTMENT... with organizations subject to FDA regulation. (a) For a period of 1 year after FDA appointment, or... employed in a regulated organization within 1 year before FDA employment shall not participate in any...
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21 CFR 1.393 - What information must FDA include in the detention order?
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false What information must FDA include in the detention... Consumption How Does Fda Order A Detention? § 1.393 What information must FDA include in the detention order? (a) FDA must issue the detention order in writing, in the form of a detention notice, signed and...
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Non-Ionizing Radiation Used in Microwave Ovens
... Human Services (HHS), U.S. Food and Drug Administration (FDA) FDA's Center for Devices and Radiological Health (CDRH) sets ... public health. These standards can be viewed on FDA's Code of Federal Regulations on Microwave Ovens . FDA ...
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OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data.
Kass-Hout, Taha A; Xu, Zhiheng; Mohebbi, Matthew; Nelsen, Hans; Baker, Adam; Levine, Jonathan; Johanson, Elaine; Bright, Roselie A
2016-05-01
The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). Using cutting-edge technologies deployed on FDA's new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges. Since its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event. With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved.
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21 CFR 1.391 - Who approves a detention order?
Code of Federal Regulations, 2013 CFR
2013-04-01
... Fda Order A Detention? § 1.391 Who approves a detention order? An authorized FDA representative, i.e., the FDA District Director in whose district the article of food involved is located or an FDA official...
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FDA Issues Final Guidance Clarifying FDA and EPA Jurisdiction over Mosquito-Related Products
FDA finalized guidance to provide information on FDA and EPA jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those products intended to function as pesticides
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21 CFR 1.391 - Who approves a detention order?
Code of Federal Regulations, 2011 CFR
2011-04-01
... Fda Order A Detention? § 1.391 Who approves a detention order? An authorized FDA representative, i.e., the FDA District Director in whose district the article of food involved is located or an FDA official...
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21 CFR 1.391 - Who approves a detention order?
Code of Federal Regulations, 2010 CFR
2010-04-01
... Fda Order A Detention? § 1.391 Who approves a detention order? An authorized FDA representative, i.e., the FDA District Director in whose district the article of food involved is located or an FDA official...
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21 CFR 1.391 - Who approves a detention order?
Code of Federal Regulations, 2012 CFR
2012-04-01
... Fda Order A Detention? § 1.391 Who approves a detention order? An authorized FDA representative, i.e., the FDA District Director in whose district the article of food involved is located or an FDA official...
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21 CFR 1.379 - How long may FDA detain an article of food?
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional 10...
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21 CFR 1.379 - How long may FDA detain an article of food?
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 1 2014-04-01 2014-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional 10...
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21 CFR 1.379 - How long may FDA detain an article of food?
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 1 2012-04-01 2012-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional 10...
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21 CFR 1.379 - How long may FDA detain an article of food?
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional 10...
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21 CFR 1.379 - How long may FDA detain an article of food?
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 1 2013-04-01 2013-04-01 false How long may FDA detain an article of food? 1.379... Provisions § 1.379 How long may FDA detain an article of food? (a) FDA may detain an article of food for a... institute a seizure or injunction action. The authorized FDA representative may approve the additional 10...
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Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D
2014-10-01
Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.
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Kuehn, Carrie M
2018-01-01
The influence of patient advocates on FDA regulatory decision making has increased. Despite enhanced engagement with FDA, there remain challenges to achieving the regulatory goals of patients within FDA's regulatory framework. Gaps exist between patient advocates' knowledge of the agency's processes and FDA's need for rigorous, clinically meaningful patient experience data. This study examined the policy process in which patient experience data are collected by patient advocates and provided to FDA for regulatory decision making. Semistructured, narrative interviews were conducted with 14 professionals working in patient advocacy or at FDA. The purpose was to examine, in depth, participants' perceptions and experiences regarding this new regulatory process. Interviews were coded and examined for themes. The use of patient experience data by FDA is an evolving regulatory process. Participants identified a number of barriers and contributors to regulatory success. Well-organized and sophisticated patient advocacy groups with access to scientific and policy expertise are more likely to find success meeting FDA's patient experience data requirements. A conceptual model of this regulatory process was developed. Use of patient experience data by FDA has the potential to positively influence the regulation of medical products in the United States. Success within this new regulatory process will depend on clear guidance from FDA regarding the collection, analysis, and use of patient experience data. Patient advocacy groups must enhance internal capacity and expertise while engaging in substantive collaborations with FDA and other stakeholders in order to meaningfully contribute to the regulatory review of new therapeutics.
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The acid/base profile of agrochemicals.
Manallack, D T
2017-08-01
Drug-likeness has long been studied in the pursuit of finding new medicines. Similarly, in the agrochemical field there is value in exploring the properties of the chemicals involved. Patterns that emerge can potentially influence future discovery campaigns to improve the probability of commercial success. In this study we investigate the acid/base properties and physicochemical characteristics of three classes of compounds: fungicides, herbicides and insecticides. In comparison with FDA-approved drugs, it was noted that the pesticides were generally smaller, possessed a neutral charge state and were more lipophilic. The results are discussed in the light of their intended targets.
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Fluorescein Diacetate Microplate Assay in Cell Viability Detection.
Chen, Xi; Yang, Xiu-Ying; Fang, Lian-Hua; DU, Guan-Hua
2016-12-20
Objective To investigate the application of the fluorescein diacetate (FDA) microplate assay in cell viability detection. Methods Cells were seeded in a 96-well culture plate until detection. After incubated with FDA,the plate was detected by fluorescence microplate analyzer. The effects of FDA incubation duration,concentration,and other factors on the assay's accuracy and stability were assessed. We also compared the results of FDA with methyl thiazolyl(MTT) in terms of cell numbers and H 2 O 2 injury. Results Within 0-30 minutes,the fluorescence-cell number coefficient of FDA assay increased with duration and reached 0.99 in 27-30 minutes. The optimum concentration of final FDA in this study was 10-30 μg/ml. On cell viability detection,the result of FDA method was equivalent to MTT method. As to H 2 O 2 injury assay,the sensitivity of FDA method was superior to MTT on the higher concentration H 2 O 2 treatment due to a relative shorter duration for detection. Conclusion As a stable and reliable method,FDA is feasible for cell variability detection under varied conditions.
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2017-10-24
The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-07
...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-28
.... FDA-2012-N-1148] FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products... comments. SUMMARY: The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain...
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Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval
2016-10-01
consensus meeting, with input from investigators in the Prostate Cancer Clinical Trials Consortium, FDA Office of Oncology Drug Products, FDA Study...Cancer Clinical Trials Consortium, FDA Office of Oncology Drug Products, FDA Study Endpoint and Label Development Team, and FDA Division of...Abstract. American Society of Clinical Oncology . Chicago IL, June 1-5, 2013. INVENTIONS, PATENTS AND LICENSES None 11 REPORTABLE OUTCOMES
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NACA Mechanics in an Allison Engine Training Class
1943-10-21
The Allison Engine Company's A.G. Covell instructs mechanics from various divisions at the National Advisory Committee for Aeronautics (NACA) Aircraft Engine Research Laboratory on the operation of the Allison Basic Engine. The military had asked that the laboratory undertake an extensive program to improve the performance of the Allison V–1710 engine. The V–1710 was the only liquid-cooled engine used during World War II, and the military counted on it to power several types of fighter aircraft. The NACA instituted an Apprentice Program during the war to educate future mechanics, technicians, and electricians. The program was suspended for a number of years due to the increasing rates of military service by its participants. The laboratory continued its in-house education during the war, however, by offering a number of classes to its employees and lectures for the research staff. The classes and lectures were usually taught by fellow members of the staff, but occasionally external experts were brought in. The students in the Allison class in the Engine Research Building were taught how to completely disassemble and reassemble the engine components and systems. From left to right are Don Vining, Ed Cudlin, Gus DiNovo, George Larsen, Charles Diggs, Martin Lipes, Harley Roberts, Martin Berwaldt and John Dempsey. A.G. Covell is standing.
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A Master Class for nursing unit managers: an Australian example.
Duffield, Christine
2005-01-01
To design and provide a Master Class leadership course for nursing unit managers. The selection and development of nursing unit managers is important to the profession and to the units they manage given their critical role in staff retention. While many in these positions are well-qualified academically they may require ongoing professional development in a cycle of continuous learning that challenges and motivates them to maintain skill mastery. A review of the literature found examples of a Master Class conducted in the arts but none in leadership development. The elements of a Master Class have been distilled from the literature and applied to the development of a programme for 18 nursing unit managers employed at four hospitals in an area health service in New South Wales (Australia). A Delphi survey using participants determined the 20 most important topics from which to construct the programme. The programme was positively evaluated by participants in aspects such as allowing the expression of opinions, networking, stretching their minds and time to reflect on their own experiences. Nursing unit managers occupy a pivotal role in health care institutions. Investing resources into the ongoing development of their leadership skills may provide significant benefits for the individuals themselves, their staff and the organization.
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Crites, Steven A; Howard, Barbara H
2011-03-01
Individuals with severe disability exiting school are likely to be enrolled in day activity and sheltered workshops at least as often as in supported employment. Such facilities are often staffed by paraprofessionals who may not have the skills to engage clients in meaningful activities. This article describes a 3-phase staff training project designed to increase client engagement in an adult habilitation centre. The first phase of the project was to develop curriculum guidelines. The second phase was conducting a series of training for paraprofessional staff. And the third was the implementation of the clinical experience. The first author conducted a graduate level methods class on site at the adult habilitation centre. Staff participants (paraprofessional staff, supervisors, and graduate students) learned the components of systematic instruction and developed and implemented activities for clients. Engagement was measured before and after the 5-week clinical experience. The engagement of clients increased with the implementation of systematic instruction following staff training. The implications are discussed.
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Patterns and predictors of violence against children in Uganda: a latent class analysis.
Clarke, Kelly; Patalay, Praveetha; Allen, Elizabeth; Knight, Louise; Naker, Dipak; Devries, Karen
2016-05-24
To explore patterns of physical, emotional and sexual violence against Ugandan children. Latent class and multinomial logistic regression analysis of cross-sectional data. Luwero District, Uganda. In all, 3706 primary 5, 6 and 7 students attending 42 primary schools. To measure violence, we used the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool-Child Institutional. We used the Strengths and Difficulties Questionnaire to assess mental health and administered reading, spelling and maths tests. We identified three violence classes. Class 1 (N=696 18.8%) was characterised by emotional and physical violence by parents and relatives, and sexual and emotional abuse by boyfriends, girlfriends and unrelated adults outside school. Class 2 (N=975 26.3%) was characterised by physical, emotional and sexual violence by peers (male and female students). Children in Classes 1 and 2 also had a high probability of exposure to emotional and physical violence by school staff. Class 3 (N=2035 54.9%) was characterised by physical violence by school staff and a lower probability of all other forms of violence compared to Classes 1 and 2. Children in Classes 1 and 2 were more likely to have worked for money (Class 1 Relative Risk Ratio 1.97, 95% CI 1.54 to 2.51; Class 2 1.55, 1.29 to 1.86), been absent from school in the previous week (Class 1 1.31, 1.02 to 1.67; Class 2 1.34, 1.10 to 1.63) and to have more mental health difficulties (Class 1 1.09, 1.07 to 1.11; Class 2 1.11, 1.09 to 1.13) compared to children in Class 3. Female sex (3.44, 2.48 to 4.78) and number of children sharing a sleeping area predicted being in Class 1. Childhood violence in Uganda forms distinct patterns, clustered by perpetrator and setting. Research is needed to understand experiences of victimised children, and to develop mental health interventions for those with severe violence exposures. NCT01678846; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
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ERIC Educational Resources Information Center
Dow, Teri Goodall
1983-01-01
A high school computer laboratory is also available for use by community members enrolled in a computer class. Equipment security is obtained by staggering the hours of teacher aides. Faculty and staff can take computers home on weekends. (MLF)
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Maréchaux, Sylvestre; Rusinaru, Dan; Jobic, Yannick; Ederhy, Stéphane; Donal, Erwan; Réant, Patricia; Arnalsteen, Elise; Boulanger, Jacques; Garban, Thierry; Ennezat, Pierre-Vladimir; Jeu, Antoine; Szymanski, Catherine; Tribouilloy, Christophe
2015-02-01
The Food and Drug Administration (FDA) criteria for diagnosis of drug-induced valvular heart disease (DIVHD) are only based on the observation of aortic regurgitation ≥ mild and/or mitral regurgitation ≥ moderate. We sought to evaluate the diagnostic value of FDA criteria in a cohort of control patients and in a cohort of patients exposed to a drug (benfluorex) known to induce VHD. This prospective, multicentre study included 376 diabetic control patients not exposed to valvulopathic drugs and 1000 subjects previously exposed to benfluorex. Diagnosis of mitral or aortic DIVHD was based on a combined functional and morphological echocardiographic analysis of cardiac valves. Patients were classified according to the FDA criteria [mitral or aortic-FDA(+) and mitral or aortic-FDA(-)]. Among the 376 control patients, 2 were wrongly classified as mitral-FDA(+) and 17 as aortic-FDA(+) (0.53 and 4.5% of false positives, respectively). Of those exposed to benfluorex, 48 of 58 with a diagnosis of mitral DIVHD (83%) were classified as mitral-FDA(-), and 901 of the 910 patients (99%) without a diagnosis of the mitral DIVHD group were classified as mitral-FDA(-). All 40 patients with a diagnosis of aortic DIVHD were classified as aortic-FDA(+), and 105 of the 910 patients without a diagnosis of aortic DIVHD (12%) were classified aortic-FDA(+). Older age and lower BMI were independent predictors of disagreement between FDA criteria and the diagnosis of DIVHD in patients exposed to benfluorex (both P ≤ 0.001). FDA criteria solely based on the Doppler detection of cardiac valve regurgitation underestimate for the mitral valve and overestimate for the aortic valve the frequency of DIVHD. Therefore, the diagnosis of DIVHD must be based on a combined echocardiographic and Doppler morphological and functional analysis of cardiac valves. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.
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21 CFR 314.103 - Dispute resolution.
Code of Federal Regulations, 2013 CFR
2013-04-01
... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.103 Dispute resolution. (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated...
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21 CFR 314.103 - Dispute resolution.
Code of Federal Regulations, 2014 CFR
2014-04-01
... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.103 Dispute resolution. (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated...
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21 CFR 314.103 - Dispute resolution.
Code of Federal Regulations, 2012 CFR
2012-04-01
... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.103 Dispute resolution. (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated...
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21 CFR 314.103 - Dispute resolution.
Code of Federal Regulations, 2011 CFR
2011-04-01
... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.103 Dispute resolution. (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated...
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21 CFR 314.103 - Dispute resolution.
Code of Federal Regulations, 2010 CFR
2010-04-01
... HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.103 Dispute resolution. (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated...
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Investigation of the interfacial reaction between metal and fluorine-contained polyimides
NASA Astrophysics Data System (ADS)
Yang, Ching-Yu; Chen, J. S.; Hsu, S. L. C.
2005-07-01
In this work, thin metal films (Cr and Ta) were deposited on fluorine-contained polyimides, 6FDA-BisAAF, and 6FDA-PPD. The chemical states of the metal/polyimide samples were characterized by using x-ray photoelectron spectroscopy (XPS). XPS analysis reveals that metal-C, C-O, and metal-O bondings are present in metallized 6FDA-BisAAF and 6FDA-PPD. C-F bonds are observed in bare 6FDA-BisAAF and 6FDA-PPD however, they are not seen in the metallized samples. Disappearance of the C-F bonding is attributed to the disruption of CF3 side groups from the main chains of 6FDA-BisAAF and 6FDA-PPD when the chains are exposed to the plasma during the metal deposition. Nevertheless, the disruption of CF3 side groups also creates sites for the formation of metal-C or C-O bondings, which provide a positive adhesion strength at the metal/polyimide interface, as revealed by the tape test.
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Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing.
Yim, Seon-Hee; Chung, Yeun-Jun
2014-12-01
In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.
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The history and contemporary challenges of the US Food and Drug Administration.
Borchers, Andrea T; Hagie, Frank; Keen, Carl L; Gershwin, M Eric
2007-01-01
The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world. The FDA thus plays an integral role in the use of pharmaceuticals, not only in the United States but worldwide. The goal of this review was to present an overview of the FDA and place its current role in the perspectives of history and contemporary needs. Relevant materials for this review were identified through a search of the English-language literature indexed on MEDLINE (through 2006) using the main search terms United States Food and Drug Administration, FDA, history of the FDA, drug approvals, drug legislation, and FDA legislation. Results from the initial searches were then explored further. The statute that created the bureau which later became the FDA established this agency to prohibit interstate commerce of adulterated foods, drinks, and drugs. The Food, Drug, and Cosmetic Act that replaced it in 1938, and subsequent food and drug laws and amendments, expanded the FDA's responsibilities to cosmetics, medical devices, biological products, and radiation-emitting products. These amendments have also established the FDA as a mainly preventive regulatory agency that relies chiefly on pre-market control. As such, the FDA has played an important role in shaping the modern pharmaceutical industry by making the scientific approach and the clinical trial process the standard for establishing safety and efficacy and by making rigorous scientific analysis the predominant component of the process for pharmaceutical regulation. As shown in this review, the evolution of the FDA can be described as a series of "crisis-legislation-adaptation" cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA. However, the crises the FDA faces currently are likely to be overcome only under strong and permanent leadership willing to redefine the role and procedures of the FDA with an open mind.