How to Submit | Center for Cancer Research

Cancer.gov

be submitted by a current NIH or FDA fellow. The work does not need to have been done at the NIH/FDA. However, the submitter must be an author on the document and be in compliance with the intended journal's authorship guidelines or general good authorship practices. 

76 FR 47593 - Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-05

...] Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission... entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.'' FDA has... consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency...

75 FR 78715 - Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0605..., or Holding Operations for Dietary Supplements; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

75 FR 76015 - Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0551] Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture... Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture...

Good manufacturing practice (GMP) compliance in the biologics sector: plasma fractionation.

PubMed

Ways, J P; Preston, M S; Baker, D; Huxsoll, J; Bablak, J

1999-12-01

The U.S. blood supply is the safest it has ever been. Due to blood safety and the introduction of viral inactivation/clearance technologies, protein therapies derived from human blood have also in recent years had a history of product safety. Nevertheless, since 1995, the plasma-fractionation industry has experienced increased compliance-related actions by the Food and Drug Administration (FDA), as shown by a substantive increase in the number of FDA 483 inspectional observations, FDA warning letters and other FDA regulatory action. An evaluation of these trends shows that they reflect the implementation by the FDA of increased inspectional interest in the plasma-fractionation industry and an evolution of inspectional practices and standards of current good manufacturing practice (cGMP). Plasma fractionators have responded to FDA actions by carefully evaluating and addressing each inspectional observation, assessing impact to product and taking appropriate actions, including corrective actions to prevent future occurrence. They have made major investments in facilities, quality systems, personnel and training to meet the evolving standards of cGMP and in an effort to implement these standards systemically. Through industry associations, manufacturers have further enhanced product safety by adopting additional voluntary standards for plasma to prevent the entry of potentially unsuitable plasma into the production process. The industry remains committed to application of cGMP and to working with the FDA in further evolution of these standards while striving to assure a continued supply of safe, pure and effective plasma-derived therapies.

Services of the CDRH X-ray calibration laboratory and their traceability to National Standards

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cerra, F.; Heaton, H.T.

The X-ray Calibration Laboratory (XCL) of the Center for Devices and Radiological Health (CDRH) provides calibration services for the Food and Drug Administration (FDA). The instruments calibrated are used by FDA and contract state inspectors to verify compliance with federal x-ray performance standards and for national surveys of x-ray trends. In order to provide traceability of measurements, the CDRH XCL is accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) for reference, diagnostic, and x-ray survey instrument calibrations. In addition to these accredited services, the CDRH XCL also calibrates non-invasive kVp meters in single- and three-phase x-ray beams, and thermoluminescentmore » dosimeter (TLD) chips used to measure CT beam profiles. The poster illustrates these services and shows the traceability links back to the National Standards.« less

78 FR 15017 - Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0643... Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled...

Your business in court and at Federal agencies: 2011-2012.

PubMed

Reiss, John B; Crowder, Dawn; McCabe, Brittany; DeFeo, Marisa; Rifin, Marta; Talbot, Meghan

2013-01-01

FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased manufacturing recalls. FDA issued more device Guidances for regulatory clarity. Enforcement involving drugs and devices increased, including GMP and GLP enforcement and surveillance of internet claims. The Supreme Court decided generic drug manufacturers may cause the FDA to revise incorrectly listed use codes, and pharmaceutical detailers may not receive overtime payments. FDA initiated implementation of the Food Safety and Modernization Act, including two pilot tracking systems for supply chain tracing and to determine how quickly data can be gathered. The Agency issued guidance for new dietary supplements. FDA failed to impose graphic labeling requirements on the tobacco industry, but established it can regulate electronic cigarettes as tobacco. The Agency issued guidelines for the use of nanomaterials in cosmetics, and reviewed the effectiveness of sunscreen products. FDA is being given more authority over larger areas of the U.S. economy, but its resources are not increased proportionately. The pharmaceutical industry made major payments for alleged violations of the Drug Rebate Statute, Anti-Kickback Statute, Wholesale Price and Off-Label Use prohibitions. The government continues using the Responsible Corporate Officer doctrine to make company managers responsible for corporate conduct about which they had no knowledge. Companies should have a robust compliance program in effect. The FTC and the SEC continue their oversight activities, including SEC's enforcement of the Foreign Corrupt Practices Act. The defense of product liability litigation continues grappling with federal preemption of state laws.

Dental radiographic guidelines: a review.

PubMed

Kim, Irene H; Mupparapu, Muralidhar

2009-05-01

The 2004 American Dental Association (ADA)/US Food and Drug Administration (FDA) radiographic selection criteria and guidelines were reviewed and compared with the prior radiographic selection criteria and guidelines. The authors reviewed the publications from the US FDA, US Department of Health and Human Services, and National Council on Radiation Protection and Measurements. The positions outlined by the Canadian Dental Association and the European Commission were also reviewed and compared to US guidelines. The FDA guidelines were first published in 1987, and several changes have been made to them over the years. Recent literature reveals that the general compliance of these guidelines is very low, especially within dental schools in the United States and Canada. Little is known about the compliance outside of the dental school environment; however, it is expected to be low for various reasons. In 2007, the International Commission on Radiological Protection (ICRP) revised its estimates of tissue radiosensitivity, which resulted in effective doses of dental radiographs 32% to 422% higher than the 1990 ICRP guidelines. Flow charts summarizing the latest guidelines were developed to facilitate general compliance among practitioners. Based on the literature reviewed and the recent ICRP findings, it would be prudent for dental health care professionals to follow dental radiographic guidelines.

77 FR 18830 - Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

... language the requirements of the regulation and to help small businesses understand and comply with the... is making available this SECG stating in plain language the legal requirements of the February 2...-regulated products. FDA is issuing this SECG as level 2 guidance consistent with FDA's good guidance...

76 FR 7866 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-11

... with the OMB control number 0910-0539. Also include the FDA docket number found in brackets in the..., Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7651, [email protected] . SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has...

77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...

76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The...

76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The...

75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop...

77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...

77 FR 25721 - Small Entity Compliance Guide: Bottled Water: Quality Standard: Establishing an Allowable Level...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-01

...] Small Entity Compliance Guide: Bottled Water: Quality Standard: Establishing an Allowable Level for di(2-ethylhexyl)phthalate; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled...

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.

78 FR 20326 - Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0126] Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration--Human and Animal Food; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0366] Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The...

77 FR 72868 - Compliance Guidance for Small Business Entities on Labeling and Effectiveness Testing; Sunscreen...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1086] Compliance Guidance for Small Business Entities on Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Notice of Availability AGENCY: Food and Drug Administration, HHS...

77 FR 38838 - Compliance Policy Guide Sec. 230.110-Registration of Blood Banks, Other Firms Collecting...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0558] Compliance Policy Guide Sec. 230.110--Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing, or Processing Human Blood or Blood Products; Withdrawal AGENCY: Food and Drug Administration, HHS...

Criminalizing knowledge: the perverse implications of the intended use regulations of off-label promotion prosecutions.

PubMed

Gentry, Gregory

2009-01-01

Your company has spent months designing a compliance program and training your sales representatives. They know never to mention the off-label uses of your product. If they are asked about the off-label uses by the physician they are detailing, they know to forward those inquiries to the scientific liaisons at headquarters. But, could your company still be in legal jeopardy simply because it knows that the product is being used for an off-label purpose? This article attempts to track the Food and Drug Administration's (FDA's) shifting interpretation of its "intended use" regulations, from focusing entirely on the statements of the manufacturers to focusing on the knowledge of the industry, indeed, of the consumers of products, in determining the true intended use of a product. It will look at several recent attempts by FDA to use that new interpretation of the regulations to expand its power: to regulate tobacco and to require pediatric indications for any new drug. Finally, it will look at several recent examples of how this new interpretation has manifested in actions by FDA and the Department of Justice (DOJ).

Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

PubMed Central

Miller, Jennifer E; Korn, David; Ross, Joseph S

2015-01-01

Objective To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome measures Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. Results The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies. Conclusions Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve compliance with legal and ethics standards and the quality of medical knowledge. PMID:26563214

TU-AB-204-02: Device Adverse Events and Compliance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gonzales, S.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

76 FR 66074 - Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-25

...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance Guide'' for a final rule published in the Federal Register on June 22, 2011. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand and comply with the regulation.

Legal considerations for social media marketing by pharmaceutical industry.

PubMed

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.

Neighborhood Inequalities in Retailers' Compliance With the Family Smoking Prevention and Tobacco Control Act of 2009, January 2014-July 2014.

PubMed

Lee, Joseph G L; Baker, Hannah M; Ranney, Leah M; Goldstein, Adam O

2015-10-08

Retailer noncompliance with limited US tobacco regulations on advertising and labeling was historically patterned by neighborhood in ways that promote health disparities. In 2010, the US Food and Drug Administration (FDA) began enforcing stronger tobacco retailer regulations under the Family Smoking Prevention and Tobacco Control Act of 2009. However, recent research has found no differences in compliance by neighborhood characteristics for FDA advertising and labeling inspections. We sought to investigate the neighborhood characteristics associated with retailer noncompliance with specific FDA advertising and labeling inspections (ie, violations of bans on self-service displays, selling single cigarettes, false or mislabeled products, vending machines, flavored cigarettes, and free samples). We coded FDA advertising and labeling warning letters (n = 718) for type of violations and geocoded advertising and labeling inspections from January 1 through July 31, 2014 (N = 33,543). Using multilevel models, we examined cross-sectional associations between types of violations and neighborhood characteristics previously associated with disparities (ie, percentage black, Latino, under the poverty line, and younger than 18 years). Retailer advertising and labeling violations are patterned by who lives in the neighborhood; regulated tobacco products are more likely to be stored behind the counter as the percentage of black or Latino residents increases, and single cigarettes are more often available for purchase in neighborhoods as the percentage of black, poor, or young residents increases. Contrary to previous null findings, noncompliance with FDA advertising and labeling regulations is patterned by neighborhood characteristics, sometimes in opposite directions. Given the low likelihood of self-service violations in the same neighborhoods that have high likelihood of single cigarette sales, we suggest targeted approaches to FDA retailer inspections and education campaigns.

Neighborhood Inequalities in Retailers’ Compliance With the Family Smoking Prevention and Tobacco Control Act of 2009, January 2014–July 2014

PubMed Central

Baker, Hannah M.; Ranney, Leah M.; Goldstein, Adam O.

2015-01-01

Introduction Retailer noncompliance with limited US tobacco regulations on advertising and labeling was historically patterned by neighborhood in ways that promote health disparities. In 2010, the US Food and Drug Administration (FDA) began enforcing stronger tobacco retailer regulations under the Family Smoking Prevention and Tobacco Control Act of 2009. However, recent research has found no differences in compliance by neighborhood characteristics for FDA advertising and labeling inspections. We sought to investigate the neighborhood characteristics associated with retailer noncompliance with specific FDA advertising and labeling inspections (ie, violations of bans on self-service displays, selling single cigarettes, false or mislabeled products, vending machines, flavored cigarettes, and free samples). Methods We coded FDA advertising and labeling warning letters (n = 718) for type of violations and geocoded advertising and labeling inspections from January 1 through July 31, 2014 (N = 33,543). Using multilevel models, we examined cross-sectional associations between types of violations and neighborhood characteristics previously associated with disparities (ie, percentage black, Latino, under the poverty line, and younger than 18 years). Results Retailer advertising and labeling violations are patterned by who lives in the neighborhood; regulated tobacco products are more likely to be stored behind the counter as the percentage of black or Latino residents increases, and single cigarettes are more often available for purchase in neighborhoods as the percentage of black, poor, or young residents increases. Conclusion Contrary to previous null findings, noncompliance with FDA advertising and labeling regulations is patterned by neighborhood characteristics, sometimes in opposite directions. Given the low likelihood of self-service violations in the same neighborhoods that have high likelihood of single cigarette sales, we suggest targeted approaches to FDA retailer inspections and education campaigns. PMID:26447548

FDA recognition of consensus standards in the premarket notification program.

PubMed

Marlowe, D E; Phillips, P J

1998-01-01

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.

21 CFR 601.27 - Pediatric studies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... action on waiver. FDA shall grant a full or partial waiver, as appropriate, if the agency finds that... treatment-limiting drug reaction; documented enhancement of compliance; or evidence of safety and...

The effects of tobacco control policies on retailer sales to minors in the USA, 2015.

PubMed

Dai, Hongying; Hao, Jianqiang

2018-05-01

Under the 2009 Family Smoking Prevention and Tobacco Control Act, the Food and Drug Administration (FDA) has been routinely inspecting tobacco retailers' compliance with under-age sales laws. We seek to identify factors associated with Retail Violation Rate for sale to minors (RVRm). We collected the tobacco retailer inspection data for 2015 from the FDA compliance check database. RVRm was calculated at the census tract level and overlaid with tobacco regulations and youth smoking prevalence at the state level. Multi-level spatial analysis was performed to examine the impacts of tobacco jurisdiction variations, youth smoking rates and neighbourhood social characteristics on RVRm. A total of 136 816 compliance checks involving minors conducted by the FDA in 2015 were analysed. A higher RVRm was associated with higher youth smoking prevalence (aRR=1.04, p<0.0001). Tobacco regulations show significant relationships with RVRm. For every one dollar increase in cigarette tax per pack, the likelihood of retail violations was reduced by 2% (aRR=0.98, p=0.03). For every 10% increase in tobacco prevention spending towards Centers for Disease Control recommended funding targets, the likelihood of retail violations was reduced by 1% (aRR=0.99, p=0.01). RVRm increased in states that enacted stronger smoke-free air policies (aRR=1.08, p<0.0001). We observed associations of tobacco regulations and neighbourhood social characteristics with tobacco retailers' compliance with under-age sales laws. This study provides evidence to support stronger tobacco regulations and control policies in reducing youth access to tobacco products. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Compounding pharmacy conundrum: "we cannot live without them but we cannot live with them" according to the present paradigm.

PubMed

Guharoy, Roy; Noviasky, John; Haydar, Ziad; Fakih, Mohamad G; Hartman, Christian

2013-04-01

Compounding pharmacies serve a critical role in modern health care to meet special patient care needs. Although the US Food and Drug Administration (FDA) has clearly delineated jurisdiction over drug companies and products manufactured under Good Manufacturing Practice (GMP) regulations to ensure quality, potency, and purity, compounding pharmacies are regulated by the State Boards and are not registered by the FDA. In recent years, some compounding pharmacies acted like a manufacturer, preparing large amounts of injectable drugs with interstate activities. Multiple outbreaks have been linked to compounding pharmacies, including a recent outbreak of fungal meningitis related to contaminated methylprednisolone, exposing > 14,000 patients in multiple states. This tragedy underscores the urgency of addressing safety related to compounding pharmacies. There is a call for action at the federal and state levels to set minimum production standards, impose new labeling conditions on compounded drugs, and require large-scale compounders be regulated by the FDA. "Industrial" compounding must come under FDA oversight, require those pharmacies to meet GMP standards, and ensure quality and safe products for patient use. Moreover, compliance with the Institute for Safe Medication Practices 2011 recommendations that any type of sterile compounding must be in compliance with the United States Pharmacopoeia chapter 797 guidelines will reduce the risk of patient harm from microbial contamination. Finally, other critical factors that require close attention include addressing injectable products compounded in hospitals and other outpatient health-care centers. The FDA and State Boards of Pharmacy must be adequately funded to exercise the oversight effectively.

Current good manufacturing practice regulation and investigational new drugs. Direct final rule.

PubMed

2006-01-17

The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled "INDs--Approaches to Complying With CGMP During Phase 1" to provide further guidance on the subject.

MedWatch, the FDA Safety Information and Adverse Event Reporting Program

MedlinePlus

... Information and Adverse Event Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share ... use. [Posted 06/01/2018] More What's New FDA Approved Safety Information DailyMed (National Library of Medicine) ...

Prevention of Salmonella enteritidis in shell eggs during production, storage, and transportation. Final rule.

PubMed

2009-07-09

The Food and Drug Administration (FDA) is issuing a final rule that requires shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and from further growth during storage and transportation, and requires these producers to maintain records concerning their compliance with the rule and to register with FDA. FDA is taking this action because SE is among the leading bacterial causes of foodborne illness in the United States, and shell eggs are a primary source of human SE infections. The final rule will reduce SE-associated illnesses and deaths by reducing the risk that shell eggs are contaminated with SE.

76 FR 60505 - Food Defense Workshop; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

... space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at... businesses, with firsthand working knowledge of FDA's regulations and compliance policies. This workshop is...

78 FR 52776 - Documents to Support Submission of an Electronic Common Technical Document; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-26

... obtain the documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmission...BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: August 20, 2013...

76 FR 66311 - Draft Documents To Support Submission of an Electronic Common Technical Document; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-26

.../DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm , or http...

78 FR 10181 - Documents To Support Submission of an Electronic Common Technical Document; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-13

... obtain the documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmission...BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: February 8, 2013...

The quest for quality blood banking program in the new millennium the American way.

PubMed

Kim, Dae Un

2002-08-01

For an industry to succeed and satisfy its customers, "QUALITY" must be a primary goal. Quality has been central to blood banking from its inception, with the evolution of a Quality Program since the opening of the first blood bank in U.S. at the Cook County Hospital in 1937. Over the ensuing decades, continuous scientific progress in blood preservation, filters, viral and blood group testing, crossmatching, automation, and computerization including bar coding, etc. has contributed to the quality and safety of the blood products and transfusion service. However, with the advent of the AIDS era, an increasingly sensitized and informed public is continuously demanding that the highest level of quality be achieved and maintained in all processes involved in providing all blood products. The Food and Drug Administration (FDA) introduced the concept of a "zero risk blood supply" as the industry goal. Furthermore, the cost containment and resource-constrained environment have changed the complexity of the quality practice. Both regulatory agencies such as the FDA, the Health Care Financing Administration [HCFA, which was recently renamed as the Centers for Medicare and Medicaid Services (CMS) in July, 2001], and the State Department of Health, and accrediting agencies, such as the American Association of Blood Banks (AABB), the College of American Pathologists (CAP), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), require blood banks and transfusion services to establish and follow a Quality Control and Quality Assurance Program for their licensing, certification and accreditation. Every laboratory has to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) quality requirements being implemented by the CMS. The FDA guidelines assist facilities in compliance with Current Good Manufacturing Practices (cGMP). The AABB's Quality System Essentials (QSE) are based on these specifications and provide additional guidance in implementing practices that assure quality and compliance with cGMP. AABB and CAP are granted "deemed status" as accrediting organizations under the CLIA '88 program by CMS, as well as JCAHO and some states. The International Standards Organization (ISO) has established international standards in most fields. The U.S. is represented in ISO by the American National Standards Institute (ANSI), and the National Committee for Clinical Laboratory Standards (NCCLS), as a global organization headquartered in the U.S., is a member of ANSI. The FDA and the AABB had begun incorporating many ISO principles into their own regulations and standards. The AABB's 10 QSEs are rooted in the 20 clauses of ISO 9000 series and compatible with their standards. In a Maslow-type model quality hierarchy by Tsiakals, so far the bottom three of the five progressive levels, Quality Control for method control, Quality Assurance for process control, and Quality System for system control have been implemented just to meet the regulatory and accrediting requirements. The next higher level, Quality Management for financial control, and the ultimate highest level, Total Quality Management for strategic control, should be our quest in this new millennium, and with the help of the AABB, ISO, FDA and all other organizations, we will achieve it. We should change our approach to quality issues from detection to prevention. We should improve the quality in transfusion practice itself by effective utilization of blood as a therapeutic resource with clear indication, maximum surgical blood order schedule, alternative transfusion such as autologous transfusion, hemodilution, and intra/post-operative blood salvage, surgical hemostasis, pharmacological hemostasis, and synthetic erythropoietin. Most importantly, implementation of the Quality Program should be something that we want to do rather than simply a burden that we have to do. A well-managed Quality Program is an effective and cost-efficient operation for the blood banks and transfusion services, and will enable us to better serve the patients for whom we exist.

78 FR 22554 - Document to Support Submission of an Electronic Common Technical Document-Specifications for File...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements...Vaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: April 10, 2013. Leslie Kux...

TU-AB-204-04: Partnerships

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ochs, R.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

Simple solution to the medical instrumentation software problem

NASA Astrophysics Data System (ADS)

Leif, Robert C.; Leif, Suzanne B.; Leif, Stephanie H.; Bingue, E.

1995-04-01

Medical devices now include a substantial software component, which is both difficult and expensive to produce and maintain. Medical software must be developed according to `Good Manufacturing Practices', GMP. Good Manufacturing Practices as specified by the FDA and ISO requires the definition and compliance to a software processes which ensures quality products by specifying a detailed method of software construction. The software process should be based on accepted standards. US Department of Defense software standards and technology can both facilitate the development and improve the quality of medical systems. We describe the advantages of employing Mil-Std-498, Software Development and Documentation, and the Ada programming language. Ada provides the very broad range of functionalities, from embedded real-time to management information systems required by many medical devices. It also includes advanced facilities for object oriented programming and software engineering.

Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

PubMed Central

Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.

2015-01-01

Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691

Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

PubMed

Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E

2015-10-01

The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.

Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

PubMed

2008-07-15

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

76 FR 67197 - Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-31

...The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 25, 2011 (76 FR 66074). The document announced the availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance Guide'' for a final rule that published in the Federal Register of June 22, 2011 (76 FR 36628). The notice published with an incorrect docket number. This document corrects that error.

Prior notice of imported food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule.

PubMed

2008-11-07

The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002."

TU-AB-204-03: Research Activities in Medical Physics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Badano, A.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

TU-AB-204-01: Device Approval Process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Delfino, J.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

78 FR 42526 - Salmonella

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0254] Salmonella Contamination of Dry Dog Food; Withdrawal of Compliance Policy Guide AGENCY: Food and Drug... entitled ``Sec. 690.700 Salmonella Contamination of Dry Dog Food (CPG 690.700)'' on October 1, 1980. CPG...

76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

... nonmember ($525.00) FDA Employee (free) Fee Waived If you need special accommodations due to a disability..., telephone, fax number, and e-mail, along with a check or money order payable to ``SoCRA''. Mail to: SoCRA...

Hand Sanitizers Carry Unproven Claims to Prevent MRSA Infections

MedlinePlus

... misled if they think these products you can buy in a drug store or from other places will protect them ... Deborah Autor, compliance director at FDA's Center for Drug Evaluation and ... claims, too—whether they buy a product from a retail store or through ...

A Roadmap for Academic Health Centers to Establish Good Laboratory Practice-Compliant Infrastructure

PubMed Central

Adamo, Joan E.; Bauer, Gerhard; Berro, Marlene; Burnett, Bruce K.; Hartman, Karen A.; Masiello, Lisa M.; Moorman-White, Diane; Rubinstein, Eric P.; Schuff, Kathryn G.

2012-01-01

Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration (FDA) regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take prior to the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials. PMID:22373618

Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting.

PubMed

Dal-Ré, Rafael; Ross, Joseph S; Marušić, Ana

2016-07-01

To examine compliance with International Committee of Medical Journal Editors' (ICMJE) policy on prospective trial registration along with predictors of compliance. Cross-sectional analysis of all articles reporting trial results published in the six highest-impact general medicine journals in January-June 2014 that were registered in a public trial registry. The main outcome measure was compliance with ICMJE policy. The time frame for trial primary end point ascertainment was used to assess whether retrospective registration could have allowed changing of primary end points following an interim analysis. Forty of 144 (28%) articles did not comply with the ICMJE policy. Trials of non-FDA-regulated interventions were less compliant than trials of FDA-regulated interventions (i.e., medicines, medical devices) (42% vs. 21%; P = 0.016). Twenty-nine of these 40 (72%; 20% overall) were registered before any interim analysis of primary end points could have been conducted; 11 (28%; 8% overall) were registered after primary end point ascertainment, such that investigators could have had the opportunity to conduct an interim analysis before trial registration. Twenty-eight percent of trials published in high-impact journals were retrospectively registered including nearly 10% that were registered after primary end point ascertainment could have had taken place. Prospective registration should be prompted and enforced to ensure transparency and accountability in clinical research. Copyright © 2016 Elsevier Inc. All rights reserved.

Your business in court and at federal agencies: 2010 - 2011.

PubMed

Reiss, John B; Crowder, Dawn; Simons, Brian; Pleskov, Igor; Davis, Tiffany; Nugent, Patrick

2012-01-01

This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as under the provisions of the Food, Drug and Cosmetics Act (FDCA). In addition, the government pursued actions against individual executives under the Responsible Corporate Officer Doctrine ("RCO Doctrine") because it does not believe sanctions against the companies provide sufficient deterrence to inappropriate behavior. Companies need to focus on implementing effective compliance programs in order to prevent the occurrence of allegedly improper activity. It should be noted that the existence of an effective program will not protect executives from liability under the RCO Doctrine if improper behavior takes place. The Food and Drug Administration's (FDA's) has undertaken a number of initiatives during the past year in an attempt to counter claims that its review processes for domestic products is driving the development of drugs and devices to overseas markets. The Agency also has improved its capacity to review products imported from overseas by undertaking initiatives with foreign agencies and stationing more FDA employees in foreign countries. The FDA increased the number of warning letters and other enforcement actions. The FDA added two new topics of enhanced authority during the year. One was an expansion of its regulatory authority over foods, and the second was new authority to regulate certain tobacco products. The former is being subjected to some review by the courts, and the scope of its authority over tobacco is the subject of ongoing major litigation. The Federal Trade Commission (FTC) and Securities and Exchange Commission (SEC) are unlikely to experience significant change regarding their regulation of Manufacturers. The FTC, as it has for many years, continues to try to prevent "reverse" payments to generic drug manufacturers by Innovator Manufacturers to diminish generic drug competition, and proposed legislation is before Congress. The SEC still appears focused on the Foreign Corporate Practices Act with respect to enforcement against pharmaceutical and device manufacturers. Federal preemption of State law continues to be a topic of concern, with Court's taking different positions on the effect of the various Supreme Court decisions made in the last two years.

75 FR 78155 - Uniform Compliance Date for Food Labeling Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-15

... labeling requirements to minimize the economic impact of label changes. On December 8, 2008, FDA... dates of these labeling changes were not coordinated, the cumulative economic impact on the food... for an orderly and economical industry adjustment to new labeling requirements by allowing sufficient...

78 FR 37228 - Cooperative Agreement To Support the Western Center for Food Safety

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-20

... Davis main campus and experimental stations provide invaluable access to one of the leading food... sites for experimental trials is instrumental to FDA receiving the most current scientifically validated... facilitate industry compliance with preventive control standards. Information gleaned from this research has...

A systematic review of compliance with palivizumab administration for RSV immunoprophylaxis.

PubMed

Frogel, Michael P; Stewart, Dan L; Hoopes, Michael; Fernandes, Ancilla W; Mahadevia, Parthiv J

2010-01-01

Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in infants and young children, accounting for approximately 75,000-125,000 hospitalizations per year. It is estimated that in 2000, RSV infection accounted for 1.7 million office visits, 402,000 emergency room visits, and 236,000 hospital outpatient visits per year for children younger than 5 years of age. Palivizumab, a humanized monoclonal antibody directed against RSV, is the only immunoprophylaxis therapy approved by the FDA for prevention of serious lower respiratory tract disease caused by RSV in infants (up to 2 years of age) who meet 1 or more of the following criteria for high risk: (a) gestational age up to 35 weeks;(b) diagnosis of chronic lung disease (CLD, formerly bronchopulmonary dysplasia [BPD]); or (c) diagnosis of cyanotic or complex congenital heart disease. The RSV season typically occurs between November and March but may vary by region. During the period of our review, depending on local duration of the RSV season, infants usually required 5 monthly (every 28-30 days) intramuscular injections of palivizumab. Infants born in the middle of the season received their palivizumab doses from the time of birth to the end of the season and, therefore, may have required less than 5 doses.It is unclear if compliance with monthly doses is a problem and whether noncompliance increases the risk of RSV hospitalizations in routine clinical practice. To (a) identify and describe compliance rates and the factors that influence parental compliance with immunoprophylaxis regimens, (b)review intervention programs and describe those that have been associated with increased compliance, and (c) summarize the association of compliance with RSV hospitalization rates. An electronic literature search was conducted using journal databases, including Ovid, Current Contents, Embase, Medline In-Process & Other Non-Indexed Citations; Ovid Medline, PubMed, and Web of Science;and an abstract database, Medical Intelligence Solution, for citations through April 2008. Specific search terms used were palivizumab with patient compliance, patient adherence, or patient persistence. Twenty-five articles and abstracts met the inclusion criteria. Available studies were mostly retrospective or observational prospective.Compliance, defined in various ways across the studies, varied between 25% and 100%, and 12 studies identified some of the factors related to noncompliance. Compliance generally was lower among Medicaid patients,African American patients, and other minorities. Ten studies (3 manuscripts and 7 abstracts) investigated the association of administration of prophylaxis through monthly home visits by a health professional with parental compliance with therapy. Most of the home-based programs were associated with higher compliance rates compared with clinic or office programs.Rates as high as 94% and 64% were achieved when Medicaid infants and infants of minority descent, respectively, received their doses through a home health program. When these infants received their doses at a clinic or office, depending on the definition of compliance, rates were 61%-100% for Medicaid infants and 44% for infants of minority descent. Reminder telephone calls to parents or caregivers, comprehensive multidisciplinary programs that included extensive counseling of parents, calendars with sticker reminders, and education in the language native to parents also were associated with increased compliance, although statistical significance was reported in only 1 study. Several studies recommended educating parents on the benefits of RSV prophylaxis, alleviating transportation and language difficulties, recognizing cultural differences and biases, and clarifying misperception of RSV illness severity. Home health programs had lower rates of RSV hospitalizations than office-based programs in 3 analyses conducted in 2 studies. In 4 other abstracts, the rates of RSV hospitalization for home health programs and office-based administration did not significantly differ. In a large, 4-season, prospective outcome study, compliant infants had lower RSV hospitalization rates than those who were not compliant under one definition of compliance (doses within 35-day intervals). RSV hospitalization rates were not significantly different using another definition of compliance (receipt of anticipated doses, expected vs. observed rates).In a large survey of 10,390 infants identified from pharmacy dispensing records, RSV hospitalization rates were 1.4% in the compliant group versus 3.1% in the noncompliant group (OR = 2.2, 95% CI = 1.4-3.5, P < 0.001).Adjustment for confounding was not reported in these studies. Medicaid and minority infants were less likely to receive scheduled palivizumab doses. Home-based programs for the administration of palivizumab have been investigated more than other interventions and are associated with improved compliance compared with office-based administration. Compliance with dosing, in general, was associated with lower RSV hospitalization rates. However, these strategies should be further investigated using well-designed studies.

76 FR 27062 - Biologics Price Competition and Innovation Act of 2009; Options for a User Fee Program for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-10

... under the Public Health Service Act (PHS Act). FDA is requesting input on the identified principles for... adhere to these principles, and performance goals for this program. FDA plans to review the comments... drug marketing applications were submitted each year for FDA review. The number of participants in the...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

21 CFR 500.88 - Regulatory method.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

75 FR 80011 - Good Laboratory Practice for Nonclinical Laboratory Studies

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

... for research or marketing permits for products regulated by FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and... requested the ability to cite compliance with the applicable good manufacturing requirements (i.e, parts 210...

75 FR 80826 - Compliance Policy Guide Sec. 527.300 Dairy Products-Microbial Contaminants and Alkaline...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0466...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... pasteurization or post-pasteurization contamination of dairy products. DATES: Submit either electronic or written...

Counterfeit Version of Botox Found in the United States

MedlinePlus

... fax, or by phone. Health care professionals and consumers can either: Complete and submit the report online: www.fda.gov/MedWatch/report.htm , or ... Continuing Education Inspections & Compliance Federal, State & Local Officials ... Content Home Latest Recalls Report an Adverse Event MedWatch Safety Alerts News Releases ...

FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence.

PubMed

Sasinowski, Frank J; Varond, Alexander J

2016-08-01

This article examines the strength of scientific and clinical evidence for FDA's nineteen non-AIDS, non-cancer Subpart H approval determinations over the Accelerated Approval program's twenty-four year existence. The authors researched the bases for FDA's determinations when an unvalidated surrogate or intermediate clinical endpoint is "reasonably likely to predict clinical benefit." The four key factors set forth in FDA's "Guidance for Industry, Expedited Programs for Serious Conditions - Drugs and Biologics" were applied to past Subpart H approvals. For the nineteen precedents, the authors found wide variances between the quantum and quality of evidence on each of the four factors, indicating that a lack of evidence on any single factor was not disqualifying in and of itself. The results of this study, therefore, show that FDA exercises extraordinarily more regulatory flexibility than either FDA's foundational statutes or even FDA' s most recent 2014 Expedited Programs Guidance explicitly express. Given recent legislative exhortations and the increasing promise of personalized medicine and translational sciences, the authors conclude that Subpart H should be further explored and utilized. The authors provide a detailed analysis of the orecedents established in the nineteen approvals.

Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy

PubMed Central

Pinkerton, JoAnn V.; Pickar, James H.

2016-01-01

Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT. Results: Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data. Conclusions: The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk. PMID:26418479

Understanding risk evaluation and mitigation strategies in organ transplantation.

PubMed

Gabardi, Steven

2011-07-01

The United States Food and Drug Administration (FDA) Amendments Act of 2007 mandated that Risk Evaluation and Mitigation Strategies (REMS) be required of manufacturers. These REMS are strategies implemented to manage known or potential risks associated with drugs and to ensure ongoing pharmacovigilance throughout the life of a pharmaceutical product, including once the product becomes available as generic. The elements of an individual REMS program consist of three levels: medication guide or patient package insert, communication plan, and elements to assure safe use (ETASU). A medication guide or patient package insert is used to help prevent serious adverse events, aid in patient decision making, and enhance drug adherence. Communication plans are used to educate health care providers and to encourage their compliance with REMS. The ETASU is a restrictive process that is implemented when it is deemed necessary to ensure that patients have safe access to products with known serious risks that would otherwise be unavailable. To review the components of REMS and specifically assess their impact on health care providers practicing within the organ transplantation arena, a literature search of the MEDLINE database (January 2007-December 2010) was performed, and published materials from the FDA and its Web site were also reviewed. In transplantation, REMS programs exist for both everolimus (medication guide and communication plan) and sirolimus (medication guide). The FDA has stated that all mycophenolic acid derivatives will be subject to a proposed REMS that has not yet been approved; however, both branded mycophenolic acid agents already have approved medication guides. The REMS are a permanent fixture in the development and marketing of pharmaceutical agents, and their further implementation in solid organ transplantation is inevitable. Transplantation providers should take a proactive role in patient education and implementation of REMS within the therapeutic area. It is imperative for health care providers to realize that the ultimate goals of REMS are to reduce the potential for serious risks and to make outcomes from the treatment of disease more predictable.

77 FR 52741 - Compliance Policy Guide Sec. 420.300 Changes in Compendial Specifications and New Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0135... Supplements; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal...

75 FR 54347 - Draft Guidance for Industry: Bar Code Label Requirements-Questions and Answers (Question 12...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

...] Draft Guidance for Industry: Bar Code Label Requirements-- Questions and Answers (Question 12 Update... Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Bar... guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar...

78 FR 12937 - Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... Act requires that all research involving children that is conducted, supported, or regulated by the... protections for children involved as subjects in research. FDA is taking this action both to comply with the... research involving children conducted, supported, or regulated by HHS be in compliance with HHS regulations...

78 FR 42960 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

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...

Good Laboratory Practice. Part 3. Implementing Good Laboratory Practice in the Analytical Lab

ERIC Educational Resources Information Center

Wedlich, Richard C.; Pires, Amanda; Fazzino, Lisa; Fransen, Joseph M.

2013-01-01

Laboratories submitting experimental results to the Food and Drug Administration (FDA) or the Environmental Protection Agency (EPA) in support of Good Laboratory Practice (GLP) nonclinical laboratory studies must conduct such work in compliance with the GLP regulations. To consistently meet these requirements, lab managers employ a "divide…

Current FDA directives for promoting public health

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hayes, A.H. Jr.

1982-03-01

The current directions of the FDA are outlined. The underlying philosophy of the FDA under the Reagan Administration is that both the private sector and the government must address the responsibilities to which they are best suited for the health-care system to work more efficiently. To facilitate this, FDA is conducting comprehensive reviews of FDA regulations and the drug-evaluation process. There are many dimensions to promoting public health, and the FDA alone cannot assure an adequate supply of safe and effective drugs. Innovative science and technology are needed to develop new drugs, followed by maximum potentiation (maximum good and leastmore » harm) after FDA approval. Hospital pharmacists have a role in maximizing the potential benefits of drugs through pharmacy and therapeutics committees. The current status of the pilot program for patient package inserts is described. The response at a recent hearing on the program indicates that the responsibility to protect the public health is shared by the government, health professions, industry, and the public. The FDA's campaign on sodium is based on that shared responsibility. By improving communication and building upon their common objections, both pharmacy and the FDA can do their jobs successfully.« less

Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain.

PubMed

Chambers, James D; May, Katherine E; Neumann, Peter J

2013-06-01

The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.

The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.

PubMed

Gupta, Ravi; Dhruva, Sanket S; Fox, Erin R; Ross, Joseph S

2017-10-01

Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P < 0.001). The number of drugs in shortage increased from 17 (50.0%) to 25 (73.5%) during the 2 years before and after, respectively (P = 0.046). The median shortage duration in the 2 years before and after voluntary approval or UDI action increased from 31 days (IQR = 0-339) to 217 days (IQR = 0-406; P = 0.053). The UDI was associated with higher drug prices and more frequent drug shortages when compared with the period before UDI action, while the approval process for these drugs did not necessarily require new clinical evidence to establish safety or efficacy. This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholars program. Ross reports receiving research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; from Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; from the FDA to establish the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency at Yale. Fox reports travel support from Oklahoma Society of Health System Pharmacists, Premier Oncology Hematology Management Society, and SEHA-United Arab Emirates. Vizient provides some financial support to the University of Utah Drug Information Service to provide summaries of drug shortage information. Gupta and Ross were responsible for the conception and design of this work, drafted the manuscript, and conducted the statistical analysis. Gupta and Fox were responsible for acquisition of data. Ross provided supervision. All authors participated in the analysis and interpretation of the data and critically revised the manuscript for important intellectual content.

77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... electronic comments on the guidance to http:[sol][sol]www.regulations.gov. Submit written comments to the... at either http:[sol][sol]www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http:[sol][sol]www.regulations.gov. Dated: April 5, 2012. David Dorsey, Acting...

78 FR 32235 - Availability of Compliance Guide for Residue Prevention and Response to Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-29

... in animals from producers who are under an injunction obtained by the FDA because of drug use... establishments to follow this final guide. As for increased testing of animals from producers under an injunction... animals are found to have non-violative levels of a drug residue because the information will likely...

76 FR 66309 - Pilot Program for Parallel Review of Medical Products; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-3180-N2] Food and Drug Administration [Docket No. FDA-2010-N-0308] Pilot Program for Parallel Review of Medical... technologies to participate in a program of parallel FDA-CMS review. The document was published with an...

Drug interactions evaluation: An integrated part of risk assessment of therapeutics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhang, Lei; Reynolds, Kellie S.; Zhao, Ping

2010-03-01

Pharmacokinetic drug interactions can lead to serious adverse events or decreased drug efficacy. The evaluation of a new molecular entity's (NME's) drug-drug interaction potential is an integral part of risk assessment during drug development and regulatory review. Alteration of activities of enzymes or transporters involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by concomitant drugs may alter drug exposure, which can impact response (safety or efficacy). The recent Food and Drug Administration (FDA) draft drug interaction guidance ( (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf)) highlights the methodologies and criteria that may be used to guide drug interaction evaluation by industrymore » and regulatory agencies and to construct informative labeling for health practitioner and patients. In addition, the Food and Drug Administration established a 'Drug Development and Drug Interactions' website to provide up-to-date information regarding evaluation of drug interactions ( (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm)). This review summarizes key elements in the FDA drug interaction guidance and new scientific developments that can guide the evaluation of drug-drug interactions during the drug development process.« less

Improving the Clinical Pharmacologic Assessment of Abuse Potential: Part 1: Regulatory Context and Risk Management.

PubMed

Sellers, Edward M

2018-02-01

This article brings to the attention of drug developers the Food and Drug Administration's (FDA's) recent final Guidance to Industry on Assessment of Abuse Potential and provides practical suggestions about compliance with the Guidance. The Guidance areas are reviewed, analyzed, and placed in the context of current scientific knowledge and best practices to mitigate regulatory risk. The Guidance provides substantial new detail on what needs to be done at all stages of drug development for central nervous system-active drugs. However, because many psychopharmacologic agents have unique preclinical and clinical features, the plan for each agent needs to be not only carefully prepared but also reviewed and approved by the FDA. Examples are provided where assumptions about interpretation of the Guidance can delay development. If the expertise and experience needed for assessing abuse potential during drug development do not exist within a company, external preclinical and clinical expert should be involved. Consultation with the FDA is encouraged and important because the specific requirements for each drug will vary.

Composition, disintegrative properties, and labeling compliance of commercially available taurine and carnitine dietary products.

PubMed

Bragg, Rebecca R; Freeman, Lisa M; Fascetti, Andrea J; Yu, Zengshou

2009-01-15

To test the quality, disintegration properties, and compliance with labeling regulations for representative commercially available taurine and carnitine dietary products. Evaluation study. 11 commercially available taurine and 10 commercially available carnitine products. For each product, the amount of taurine or carnitine was determined and compared with the label claim. All products were evaluated for concentrations of mercury, arsenic, and selenium. Disintegration properties of 5 taurine and 8 carnitine products were determined in vitro. Labels were evaluated for compliance with FDA guidelines. 10 of 11 taurine and 10 of 10 carnitine products were within 10% of the stated label claim. Three of 11 taurine and 6 of 10 carnitine products were within 5% of the stated label claim. The median percentage difference between laboratory analysis and label claim was -5.7% (range, -26.3% to 2.5%) for taurine and 3.6% (range, -2.6% to 8.8%) for carnitine. No substantial amount of contamination with mercury, arsenic, or selenium was found in any of the products. During disintegration testing, 1 of 5 taurine products and 5 of 8 carnitine products did not disintegrate within 45 minutes during at least 1 test. Disintegration time for those that did disintegrate ranged from 1.7 to 37.0 minutes. All product labels conformed with FDA regulations. Taurine and carnitine products evaluated in this study closely adhered to manufacturer claims and labeling guidelines. However, disintegration testing suggested high variability in some products, possibly limiting uptake and use by animals that receive them.

76 FR 4919 - Regulatory Site Visit Training Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0046] Regulatory Site Visit Training Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is...

75 FR 6404 - Regulatory Site Visit Training Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0045] (formerly Docket No. 2004N-0408) Regulatory Site Visit Training Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics...

77 FR 55480 - Draft Compliance Policy Guide Sec. 690.150 on Labeling and Marketing of Nutritional Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-10

... for Use To Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats; Availability AGENCY..., Treat, or Prevent Disease in Dogs and Cats.'' This draft CPG is intended to provide guidance to FDA... marketing of dog and cat food products that are labeled and/or marketed as intending to diagnose, cure...

75 FR 58396 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-24

..., [email protected] . SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has... of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e) sets forth the requirements... necessary to meet this requirement is 20 hours. Application in Sec. 814.20(a) through (c) and (e) The...

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

PubMed Central

Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-01-01

Objectives To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Design Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data sources Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Outcome measures Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. Results The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%–100%) of trials in patients were registered, 71% (IQR 57%–100%) reported results or shared a CSR synopsis, 80% (70%–100%) were published and 96% (80%–100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%–100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Conclusions Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies’ transparency records and recognise exemplary companies may encourage further progress. PMID:29208616

Development of a Course of Study in FDA Drug Regulatory Procedures

ERIC Educational Resources Information Center

Jacobs, Robin Wills; King, James C.

1977-01-01

It is evident that more colleges of pharmacy should establish some major course of study in the area of governmental drug regulatory procedures. This study is aimed at expanding cooperative educational programs through an FDA residency for pharmacy students and preparing a didactic course in FDA procedures. (LBH)

75 FR 10806 - Training Program for Regulatory Project Managers; Information Available to Industry

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0108] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) Center for Drug Evaluation...

78 FR 8544 - Training Program for Regulatory Project Managers; Information Available to Industry

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2003-N-0453] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug...

75 FR 47820 - Generic Drug User Fee; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381... fee program. The number of human generic drug applications awaiting FDA action and the median review... needed for presentations, FDA reserves the right to terminate the meeting early. If you need special...

78 FR 65332 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

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...

77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

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...

Access to F.D.A. Information.

ERIC Educational Resources Information Center

Sinovic, Dianna

Prior to the enactment of the Freedom of Information Act (FOIA), little of the data collected by the Food and Drug Administration (FDA) was made public or could be obtained from the agency. Although the FDA files are now open, information is considered exempt from public disclosure when it involves regulatory procedures, program guidelines, work…

78 FR 950 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

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...

Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis.

PubMed

Pearson-Stuttard, Jonathan; Kypridemos, Chris; Collins, Brendan; Mozaffarian, Dariush; Huang, Yue; Bandosz, Piotr; Capewell, Simon; Whitsel, Laurie; Wilde, Parke; O'Flaherty, Martin; Micha, Renata

2018-04-01

Sodium consumption is a modifiable risk factor for higher blood pressure (BP) and cardiovascular disease (CVD). The US Food and Drug Administration (FDA) has proposed voluntary sodium reduction goals targeting processed and commercially prepared foods. We aimed to quantify the potential health and economic impact of this policy. We used a microsimulation approach of a close-to-reality synthetic population (US IMPACT Food Policy Model) to estimate CVD deaths and cases prevented or postponed, quality-adjusted life years (QALYs), and cost-effectiveness from 2017 to 2036 of 3 scenarios: (1) optimal, 100% compliance with 10-year reformulation targets; (2) modest, 50% compliance with 10-year reformulation targets; and (3) pessimistic, 100% compliance with 2-year reformulation targets, but with no further progress. We used the National Health and Nutrition Examination Survey and high-quality meta-analyses to inform model inputs. Costs included government costs to administer and monitor the policy, industry reformulation costs, and CVD-related healthcare, productivity, and informal care costs. Between 2017 and 2036, the optimal reformulation scenario achieving the FDA sodium reduction targets could prevent approximately 450,000 CVD cases (95% uncertainty interval: 240,000 to 740,000), gain approximately 2.1 million discounted QALYs (1.7 million to 2.4 million), and produce discounted cost savings (health savings minus policy costs) of approximately $41 billion ($14 billion to $81 billion). In the modest and pessimistic scenarios, health gains would be 1.1 million and 0.7 million QALYS, with savings of $19 billion and $12 billion, respectively. All the scenarios were estimated with more than 80% probability to be cost-effective (incremental cost/QALY < $100,000) by 2021 and to become cost-saving by 2031. Limitations include evaluating only diseases mediated through BP, while decreasing sodium consumption could have beneficial effects upon other health burdens such as gastric cancer. Further, the effect estimates in the model are based on interventional and prospective observational studies. They are therefore subject to biases and confounding that may have influenced also our model estimates. Implementing and achieving the FDA sodium reformulation targets could generate substantial health gains and net cost savings.

77 FR 36277 - Academic Development of a Training Program for Good Laboratory Practices in High Containment...

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...

Medical Device Plug-and-Play (MD PnP) Interoperability Standardization Program Development

DTIC Science & Technology

2009-08-01

TATRC / DoD Sandy Weininger, FDA / CDRH ICE-PAC / Industry Tracy Rausch, DocBox Inc. Ken Fuchs, Draeger Medical Carl Wallroth, Draeger Medical...Systems (LSTAT) Paul Jones, FDA / CDRH Kamran Sayrafian-Pour, NIST © 2006-2009 a white paper from the MD PnP Program rev July 2009 Advancing

Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world.

PubMed

Caldron, Paul H; Gavrilova, Svetlana I; Kropf, Siegfried

2012-01-01

Since the mid-1990s, investigational sites in the countries of Central and Eastern Europe (CEE) have been increasingly utilized by pharmaceutical companies because of their high productivity in terms of patient enrolment into clinical trials. Based on the FDA's publicly accessible Clinical Investigator Inspection List, we present an analysis of findings and outcome classifications from FDA inspections during Investigational New Drug (IND) studies and compare the results for the CEE region to those from Western European countries and the USA. Data from all 5531 FDA clinical trials inspections that occurred between 1994 (when the FDA first performed inspections in CEE) and the end of 2010 were entered into the database for comparative analysis. Of these, 4865 routine data audit (DA) inspections were analyzed: 401 from clinical trials performed in Western Europe, 230 in CEE, 3858 in the USA, and 376 in other countries. The average number of deficiencies per inspection ranged between 0.99 for CEE and 1.97 in Western Europe. No deficiencies were noted during 16.6%, 39.0%, and 21.5% of the inspections in Western Europe, CEE and USA, respectively. The percentages of inspections after which no follow-up action was indicated were 36.9% for Western Europe, 55.7% for CEE, and 44.3% for US sites. CEE was also the region with the lowest percentage of inspections that required official or voluntary action. On the basis of FDA inspection data, the high productivity of CEE sites appears to be accompanied by regulatory compliance as well as by data quality standards that are not inferior to those in Western regions.

Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.

PubMed

Moore, Thomas J; Furberg, Curt D; Mattison, Donald R; Cohen, Michael R

2016-06-01

Adverse drug event reports to the US Food and Drug Administration (FDA) remain the primary tool for identifying serious drug adverse effects without adequate existing warnings. We assessed the completeness of reports the FDA received in 2014. Serious adverse drug event reports were evaluated for whether they included age, gender, event date, and at least one medical term describing the event in computer excerpts. Report sources were direct reports to the FDA, manufacturer expedited reports about events without adequate warnings, and manufacturer periodic reports about events with existing warnings. In 2014, the FDA received 528,192 new case reports indicating a serious or fatal outcome, 25,038 (4.7%) directly from health professionals and consumers, and 503,154 (95.3%) from drug manufacturers. Overall, 21,595 (86.2%) of serious reports submitted directly to the FDA provided data for all four completeness variables, compared with 271,022 (40.4%) of manufacturer expedited reports and 24,988 (51.3%) of periodic reports. Among manufacturer serious reports, 37.9% lacked age and 46.9% had no event date. Performance by 25 manufacturers submitting 5000 or more reports varied from 24.4% complete on all variables to 67% complete. Patient death cases had the lowest completeness scores in all categories. By these measures, report completeness from drug manufacturers was poor compared with direct submissions to the agency. The FDA needs to update reporting requirements and compliance policies to help industry capture better adverse event information from new forms of manufacturer interactions with health professionals and consumers. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Academic and Demographic Predictors of NCLEX-RN Pass Rates in First- and Second-Degree Accelerated BSN Programs.

PubMed

Kaddoura, Mahmoud A; Flint, Elizabeth P; Van Dyke, Olga; Yang, Qing; Chiang, Li-Chi

Relatively few studies have addressed predictors of first-attempt outcomes (pass-fail) on the National Council Licensure Examination-Registered Nurses (NCLEX-RN) for accelerated BSN programs. The purpose of this study was to compare potential predictors of NCLEX outcomes in graduates of first-degree accelerated (FDA; n=62) and second-degree accelerated (SDA; n=173) BSN programs sharing a common nursing curriculum. In this retrospective study, bivariate analyses and multiple logistic regression assessed significance of selected demographic and academic characteristics as predictors of NCLEX-RN outcomes. FDA graduates were more likely than SDA graduates to fail the NCLEX-RN (P=.0013). FDA graduates were more likely to speak English as a second or additional language (P<.0001), have lower end-of-program GPA and HESI Exit Exam scores (both P<.0001), and have a higher proportions of grades ≤ C (P=.0023). All four variables were significant predictors of NCLEX-RN outcomes within both FDA and SDA programs. The only significant predictors in adjusted logistic regression of NCLEX-RN outcome for the pooled FDA+SDA graduate sample were proportion of grades ≤ C (a predictor of NCLEX-RN failure) and HESI Exit Exam score (a predictor of passing NCLEX-RN). Grades of C or lower on any course may indicate inadequate mastery of critical NCLEX-RN content and increased risk of NCLEX-RN failure. Copyright © 2016 Elsevier Inc. All rights reserved.

The in vitro and in vivo genotoxicity of benzocaine: a brief communication.

PubMed

Brock, William J; Bell, Thomas A

2012-06-01

Benzocaine has a long history of use in human medicine. However, benzocaine also has been used in aquaculture with finfish for more than 40 years for sedating fish for marking, transport, surgery, and so on, although benzocaine does not have a current Food and Drug Administration (FDA) approval for this application in the United States. As part of a FDA approval for use as an animal drug, the genotoxicity of benzocaine was evaluated in the in vitro bacterial reverse mutation assay and the forward mutation assay and in vivo in the mouse micronucleus assay. These studies were conducted in compliance with Good Laboratory Practice regulations and according to Veterinary International Conference on Harmonisation guidelines. Based on the results of these studies, benzocaine was determined not to be genotoxic.

77 FR 59287 - National Organic Program (NOP); Sunset Review (2012) for Nutrient Vitamins and Minerals

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-27

... Value (DRV). FDA stated that substances such as omega-3 and omega-6 fatty acids, inositol, choline....\\3\\ The reference to 21 CFR 104.20 refers to the fortification policy for food under the FDA's... those nutrients. \\3\\ FDA Response to NOP--Questions and Answers Regarding Nutrient Fortification of...

Dofetilide

MedlinePlus

... than normal) If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/ ...

A Descriptive Longitudinal Study of Changes in Vape Shop Characteristics and Store Policies in Anticipation of the 2016 FDA Regulations of Tobacco Products, Including E-Cigarettes.

PubMed

Yu, Sheila; Escobedo, Patricia; Garcia, Robert; Cruz, Tess Boley; Unger, Jennifer B; Baezconde-Garbanati, Lourdes; Meza, Leah; Sussman, Steve

2018-02-11

After proposing the "Deeming Rule" in 2014, the U.S. Food and Drug Administration (FDA) began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette) products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles-area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations) at two time points one year apart to better understand what vape shop retailers would do given FDA's soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014) and Year 2 surveying 61 shops (2015-2016). Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2) were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule). Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc.) over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations.

75 FR 69093 - Prescription Drug User Fee Act; Reopening of the Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... review program after negotiations with the regulated industry conclude. FDA expects that this additional...)(2) (21 U.S.C. 379h-2(d)(2)) of the FD&C Act requires that before FDA begins negotiations with the... requires public review of the recommendations for the human drug review program after negotiations with the...

MRI (Magnetic Resonance Imaging)

MedlinePlus

... IV in the arm. MRI Research Programs at FDA Magnetic Resonance Imaging (MRI) Safety Electromagnetic Modeling Related ... Resonance Imaging Equipment in Clinical Use (March 2015) FDA/CDER: Information on Gadolinium-Based Contrast Agents Safety ...

Dietary supplements quality analysis tools from the United States Pharmacopeia.

PubMed

Sarma, Nandakumara; Giancaspro, Gabriel; Venema, Jaap

2016-01-01

The United States Food and Drug Administration (FDA) issued the dietary supplement (DS) current good manufacturing practice (GMP) regulations in compliance with the mandate from the Dietary Supplements Health and Education Act (DSHEA), with the intention of protecting public health by ensuring the quality of DS. The GMP regulations require manufacturers to establish their own quality specifications for identity, purity, strength, composition, and absence of contaminants. Numerous FDA-conducted GMP inspections found that the private specifications set by these manufacturers are often insufficient to ensure adequate quality of dietary ingredients and DS. Wider use of the public standards developed by the United States Pharmacopeial Convention (USP), in conjunction with GMP compliance, can help ensure quality and consistency of DS as they do for medicines. Public health protection could be enhanced by strengthening the GMP provisions to require conformance with relevant United States Pharmacopeia-National Formulary (USP-NF) standards, or in the absence of USP standards, other public compendial standards. Another serious concern is the presence of synthetic drugs and drug analogues in products marketed as DS. Use of the new USP General Chapter Adulteration of Dietary Supplements with Drugs and Drug Analogs <2251> may reduce the exposure of consumers to dangerous drugs disguised as DS. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

34 CFR 379.51 - What are the program compliance indicators?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 2 2010-07-01 2010-07-01 false What are the program compliance indicators? 379.51... Compliance Indicator Requirements Must a Grantee Meet To Receive Continuation Funding? § 379.51 What are the program compliance indicators? (a) General. The program compliance indicators implement program evaluation...

34 CFR 379.51 - What are the program compliance indicators?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 2 2011-07-01 2010-07-01 true What are the program compliance indicators? 379.51... Compliance Indicator Requirements Must a Grantee Meet To Receive Continuation Funding? § 379.51 What are the program compliance indicators? (a) General. The program compliance indicators implement program evaluation...

77 FR 73662 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

... received by the Agency under the Pre-IDE program over the past 10 years. Based on FDA's experience with the... rate and reach a steady state of approximately 2,544 submissions per year. FDA estimates from past... annual estimate of 2,544 submissions is based on experienced trends over the past several years. FDA's...

Rufinamide

MedlinePlus

... unusual problems while taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/ ...

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

PubMed

Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

2013-01-22

The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5 ± 16.2) and Obama (41.7 ± 11.1). Most regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceutical companies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required.

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.

PubMed

Miller, Jennifer E; Wilenzick, Marc; Ritcey, Nolan; Ross, Joseph S; Mello, Michelle M

2017-12-05

To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies' transparency records and recognise exemplary companies may encourage further progress. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

12 CFR 1710.19 - Compliance and risk management programs; compliance with other laws.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Compliance and risk management programs... Practices and Procedures § 1710.19 Compliance and risk management programs; compliance with other laws. (a... management program. (1) An Enterprise shall establish and maintain a risk management program that is...

Building a roadmap to biomarker qualification: challenges and opportunities.

PubMed

Amur, Shashi G; Sanyal, Sarmistha; Chakravarty, Aloka G; Noone, Marianne H; Kaiser, James; McCune, Susan; Buckman-Garner, ShaAvhree Y

2015-01-01

The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a biomarker for a specific context of use (COU). The qualified biomarker can then be used in multiple drug development programs for this COU without re-review. Here, we describe some of the features of the BQP and two new initiatives that have the potential to aid biomarker development through early interactions with the FDA. Finally, we discuss some of the feedback the FDA has received from submitters and the BQP's actions to strengthen the program.

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

PubMed

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.

Pemetrexed long-term maintenance treatment leading to multiple finger amputation; cardiovascular complications after energy drink consumption; compartment syndrome due to extravasation of intravenous contrast; blue-gray mucocutaneous discoloration with ezogabine.

PubMed

Mancano, Michael A

2015-02-01

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's Med Watch program and Temple University School of Pharmacy. ISMP is an FDA Med Watch partner.

ISMP Adverse Drug Reactions: Pregabalin-Induced Stuttering Nitroglycerine-Induced Bradycardia Progressing to Asystole Minocycline-Induced DRESS Leading to Liver Transplantation and Type 1 Diabetes Increased Risk of Vertebral Fractures in Women Receiving Thiazide or Loop Diuretics Gambling Disorder and Impulse Control Disorder with Aripiprazole.

PubMed

Mancano, Michael A

2017-04-01

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

Phosphodiesterase type 5 inhibitor abuse: a critical review.

PubMed

Lowe, Gregory; Costabile, Raymond

2011-06-01

Abuse of sildenafil has been reported since its introduction in 1999 and commonly documented in combination with illicit drugs among men and women of all ages. Increased risks of sexually transmissible diseases including HIV have been associated with sildenafil use in men who have sex with men. Recognizing the abuse potential of phosphodiesterase type 5 inhibitors (PDE5), we aim to summarize the current knowledge of this abuse. An investigation of EMBASE, PubMed, the Food and Drug Administration (FDA) website, MedWatch, and search engines was performed to evaluate information regarding sildenafil, tadalafil, and vardenafil abuse. The EMBASE search provided 46 articles fitting the search criteria and evaluation led to 21 separate publications with specific information regarding PDE5 abuse. A PubMed search found 10 additional publications. MedWatch reported 44 separate warnings since 2000, most of which reported contamination of herbal products with active drug components. Few reports of abuse were among the 14,818 reports in the FDA AERS for sildenafil. A search for "internet drug store" revealed 6.4 million hits and of 7000 internet pharmacies identified by the Verified Internet Pharmacy Practice Sites Program (VIPPS) only 4% were in proper compliance. The role internet pharmacies play in counterfeit PDE5 or abuse is not well documented; however based on easy access, direct patient marketing, and low advertised cost it is likely this role is underreported. Currently the best recommendation for providers is to recognize the possibility of abuse and to educate patients on risks of this behavior.

Amphotericin B Injection

MedlinePlus

... antifungals. It works by slowing the growth of fungi that cause infection. ... 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).

Caspofungin Injection

MedlinePlus

... echinocandins. It works by slowing the growth of fungi that cause infection. ... 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).

New OTC drugs and devices 2003: a selective review.

PubMed

Newton, Gail D; Pray, W Steven; Popovich, Nicholas G

2004-01-01

To present current information about trends development and marketing of over-the-counter (OTC) medications and dietary supplement products and describe new products, delivery systems, home monitoring devices, and home accessories in these markets that are likely generating questions from or posing potential problems for patients. Recently published clinical and pharmaceutical industry literature. By the authors. By the authors. Last year witnessed the first effort of the Food and Drug Administration (FDA) to remove a dietary supplement from the U.S. market. Ephedra, because of its imminent danger when used for weight reduction and athletic enhancement, was the target of FDA action. FDA has issued a final rule implementing this ban, which prohibits the sale of dietary supplements containing ephedrine alkaloids (e.g., ephedra). Two newer diet-aid products are being actively promoted with little or no safety and effectiveness data. Thus, pharmacist's vigilance is important along with sensible advice on how to lose weight safely and effectively. Further, two independent organizations have created certification programs for dietary supplements that ensure product purity, active ingredient strength, and compliance with good manufacturing practices. In addition, through recent changes in federal legislation, consumers are now able to obtain reimbursement for their nonprescription purchases through flexible spending accounts. Information is presented in this article about selected products in these OTC, home care, and dietary supplement categories: heartburn (proton pump inhibitors), allergy (second-generation antihistamines), constipation (laxatives), diabetes mellitus (blood glucose monitoring systems), home testing (fertility monitoring), nicotine addiction (smoking cessation products), otic disorders (ear syringes), contraceptives and sexual aids (condoms and lubricants), and dermatology (wart removal). Patients continue to increase their reliance on self-care. To assist them, pharmacists must remain up-to-date on trends and have an understanding of the nuances of consumers' behavior and thinking in relation to OTC products and their use.

Applying your corporate compliance skills to the HIPAA security standard.

PubMed

Carter, P I

2000-01-01

Compliance programs are an increasingly hot topic among healthcare providers. These programs establish policies and procedures covering billing, referrals, gifts, confidentiality of patient records, and many other areas. The purpose is to help providers prevent and detect violations of the law. These programs are voluntary, but are also simply good business practice. Any compliance program should now incorporate the Health Insurance Portability and Accountability Act (HIPAA) security standard. Several sets of guidelines for development of compliance programs have been issued by the federal government, and each is directed toward a different type of healthcare provider. These guidelines share certain key features with the HIPAA security standard. This article examines the common areas between compliance programs and the HIPAA security standard to help you to do two very important things: (1) Leverage your resources by combining compliance with the security standard with other legal and regulatory compliance efforts, and (2) apply the lessons learned in developing your corporate compliance program to developing strategies for compliance with the HIPAA security standard.

Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis

PubMed Central

Huang, Yue; Bandosz, Piotr; Capewell, Simon; Wilde, Parke

2018-01-01

Background Sodium consumption is a modifiable risk factor for higher blood pressure (BP) and cardiovascular disease (CVD). The US Food and Drug Administration (FDA) has proposed voluntary sodium reduction goals targeting processed and commercially prepared foods. We aimed to quantify the potential health and economic impact of this policy. Methods and findings We used a microsimulation approach of a close-to-reality synthetic population (US IMPACT Food Policy Model) to estimate CVD deaths and cases prevented or postponed, quality-adjusted life years (QALYs), and cost-effectiveness from 2017 to 2036 of 3 scenarios: (1) optimal, 100% compliance with 10-year reformulation targets; (2) modest, 50% compliance with 10-year reformulation targets; and (3) pessimistic, 100% compliance with 2-year reformulation targets, but with no further progress. We used the National Health and Nutrition Examination Survey and high-quality meta-analyses to inform model inputs. Costs included government costs to administer and monitor the policy, industry reformulation costs, and CVD-related healthcare, productivity, and informal care costs. Between 2017 and 2036, the optimal reformulation scenario achieving the FDA sodium reduction targets could prevent approximately 450,000 CVD cases (95% uncertainty interval: 240,000 to 740,000), gain approximately 2.1 million discounted QALYs (1.7 million to 2.4 million), and produce discounted cost savings (health savings minus policy costs) of approximately $41 billion ($14 billion to $81 billion). In the modest and pessimistic scenarios, health gains would be 1.1 million and 0.7 million QALYS, with savings of $19 billion and $12 billion, respectively. All the scenarios were estimated with more than 80% probability to be cost-effective (incremental cost/QALY < $100,000) by 2021 and to become cost-saving by 2031. Limitations include evaluating only diseases mediated through BP, while decreasing sodium consumption could have beneficial effects upon other health burdens such as gastric cancer. Further, the effect estimates in the model are based on interventional and prospective observational studies. They are therefore subject to biases and confounding that may have influenced also our model estimates. Conclusions Implementing and achieving the FDA sodium reformulation targets could generate substantial health gains and net cost savings. PMID:29634725

Evaluation of an investigational wearable injector in healthy human volunteers.

PubMed

Torjman, Marc C; Machnicki, Robert; Lessin, Jennifer; Loeum, Channy; Steinberger, Douglas; Mycroft, Sarah; Joseph, Jeffrey I

2017-01-01

Introduction of a wearable device for subcutaneous delivery of larger volume bolus injections would encourage patient compliance and reduce the burden on healthcare services. With one such wearable device commercially available, this study examined the safety and functionality of an investigational device in volunteers. Four devices were applied to the subject's abdomen: 1) Investigational Device, 2) Investigational Device: subject movement, 3) Control Device: FDA-cleared syringe driver with FDA-cleared infusion set, 4) Control Device: FDA-cleared syringe driver attached to investigational device. Three milliliters of saline were infused through the four devices over 3 minutes. 84 devices were applied to 21 subjects. Three milliliters of saline were safely delivered subcutaneously from the investigational and control devices. Two control devices had occlusions and in each case the pump reached its high pressure limit of 12 psi. VAS pain measurements showed minimal pain for all subjects. Pain scores were significantly (p < 0.001) higher than baseline at the end of injection: mean pain level ranged from 2.0-22.0 mm. The investigational device performed as intended with minimal pain during needle insertion and infusion, and no leaking of fluid at the skin puncture site. Two occlusions occurred with the control devices.

OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

PubMed

Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

2016-01-01

Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.

Interview with Janet Woodcock: progress on the FDA's critical path initiative.

PubMed

Woodcock, Janet

2009-12-01

Janet Woodcock is the Director of the US FDA's Center for Drug Evaluation and Research. Dr Woodcock has held various positions within the FDA's Office of the Commissioner from October 2003 until 1 April, 2008, as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer and Director of the Critical Path Programs. She oversaw scientific and medical regulatory operations for the FDA. Dr Woodcock served as Director of the Center for Drug Evaluation and Research at the FDA from 1994 to 2005. She previously served in other positions at the FDA including Director of the Office of Therapeutics Research and Review and Acting Deputy Director of the Center for Biologics Evaluation and Research. Dr Woodcock received her MD from Northwestern Medical School (IL, USA), and completed further training and held teaching appointments at the Pennsylvania State University (PA, USA)and the University of California in San Francisco (CA, USA). She joined the FDA in 1986.

7 CFR 772.3 - Compliance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 7 2011-01-01 2011-01-01 false Compliance. 772.3 Section 772.3 Agriculture... SPECIAL PROGRAMS SERVICING MINOR PROGRAM LOANS § 772.3 Compliance. (a) Requirements. No Minor Program... will conduct a compliance review of all Minor Program borrowers, to determine if a borrower has...

7 CFR 772.3 - Compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 7 2010-01-01 2010-01-01 false Compliance. 772.3 Section 772.3 Agriculture... SPECIAL PROGRAMS SERVICING MINOR PROGRAM LOANS § 772.3 Compliance. (a) Requirements. No Minor Program... will conduct a compliance review of all Minor Program borrowers, to determine if a borrower has...

A Descriptive Longitudinal Study of Changes in Vape Shop Characteristics and Store Policies in Anticipation of the 2016 FDA Regulations of Tobacco Products, Including E-Cigarettes

PubMed Central

Escobedo, Patricia; Baezconde-Garbanati, Lourdes; Meza, Leah; Sussman, Steve

2018-01-01

After proposing the “Deeming Rule” in 2014, the U.S. Food and Drug Administration (FDA) began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette) products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles–area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations) at two time points one year apart to better understand what vape shop retailers would do given FDA’s soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014) and Year 2 surveying 61 shops (2015–2016). Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2) were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule). Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc.) over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations. PMID:29439464

Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world

PubMed Central

Caldron, Paul H; Gavrilova, Svetlana I; Kropf, Siegfried

2012-01-01

Since the mid-1990s, investigational sites in the countries of Central and Eastern Europe (CEE) have been increasingly utilized by pharmaceutical companies because of their high productivity in terms of patient enrolment into clinical trials. Based on the FDA’s publicly accessible Clinical Investigator Inspection List, we present an analysis of findings and outcome classifications from FDA inspections during Investigational New Drug (IND) studies and compare the results for the CEE region to those from Western European countries and the USA. Data from all 5531 FDA clinical trials inspections that occurred between 1994 (when the FDA first performed inspections in CEE) and the end of 2010 were entered into the database for comparative analysis. Of these, 4865 routine data audit (DA) inspections were analyzed: 401 from clinical trials performed in Western Europe, 230 in CEE, 3858 in the USA, and 376 in other countries. The average number of deficiencies per inspection ranged between 0.99 for CEE and 1.97 in Western Europe. No deficiencies were noted during 16.6%, 39.0%, and 21.5% of the inspections in Western Europe, CEE and USA, respectively. The percentages of inspections after which no follow-up action was indicated were 36.9% for Western Europe, 55.7% for CEE, and 44.3% for US sites. CEE was also the region with the lowest percentage of inspections that required official or voluntary action. On the basis of FDA inspection data, the high productivity of CEE sites appears to be accompanied by regulatory compliance as well as by data quality standards that are not inferior to those in Western regions. PMID:22563236

OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data.

PubMed

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.

Interview with Janet Woodcock.

PubMed

Woodcock, Janet

2010-09-01

Dr Janet Woodcock is the Director of the US FDA's Center for Drug Evaluation and Research. Dr Woodcock has held various positions within the FDA's Office of the Commissioner from October 2003 until 1 April 2008, as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer and Director of the Critical Path Programs. She oversaw scientific and medical regulatory operations for the FDA. Dr Woodcock served as Director of the Center for Drug Evaluation and Research at the FDA from 1994 to 2005. She previously served in other positions at the FDA, including Director of the Office of Therapeutics Research and Review and Acting Deputy Director of the Center for Biologics Evaluation and Research. Dr Woodcock received her MD from Northwestern Medical School (IL, USA), and completed further training and held teaching appointments at the Pennsylvania State University (PA, USA) and the University of California in San Francisco (CA, USA). She joined the FDA in 1986.

US stem cell clinics, patient safety, and the FDA.

PubMed

Turner, Leigh

2015-05-01

Scholarship on patients accessing unproven stem cell interventions is dominated by research addressing 'stem cell tourism' to such countries as China, India, Mexico, and the Ukraine. However, clinics marketing 'adipose-derived mesenchymal stem cell treatments' are proliferating across the USA. These businesses typically claim to operate in compliance with federal regulations, but careful review of their commercial practices suggests that such clinics are marketing unapproved and noncompliant biological drugs. Copyright © 2015 Elsevier Ltd. All rights reserved.

Eliminating NVA Requirements & Improving the Inspection System

DTIC Science & Technology

2011-01-27

Wg ISPR Blood Pgm QA JTAC Stan/Eval Formal Joint Comm AAAHC SCI Security Pgm Review Pathologists WII Ed & Dev Inter vent. Servi ces FDA Pubs...his/her tour  Balanced mix of scheduled & no-notice inspections  Units will be inspected for Readiness and Compliance every 24 months  Readiness...a whole  IG Team Chiefs drive team effectiveness, are the most visible direct representatives of MAJCOM CCs & should be selected by CIP or a board

Specific pathologist responses for Standard for Exchange of Nonclinical Data (SEND).

PubMed

Watanabe, Atsushi; Kusuoka, Osamu; Sato, Norihiro; Nakazono, Osamu; Wasko, Michael; Potenta, Daniel; Nakae, Dai; Hatakeyama, Hirofumi; Iwata, Hijiri; Naota, Misaki; Anzai, Takayuki

2017-07-01

The Standard for Exchange of Nonclinical Data (SEND), introduced by the US Food and Drug Administration (FDA), is a scheme for the computerization, electronic application, and screening of preclinical data. Since its establishment, related organizations have been working together to implement SEND. However, it is difficult for individual pharmaceutical companies that often outsource to achieve complete compliance with SEND; hence, the cooperation of contract research organizations (CROs) and SEND Registered Solution Providers (RSPs) is indispensable. In SEND, most data, including those on pathology findings, are converted into controlled terminology (CT), but it is not a simple process to convert findings or levels of severity in the field of pathology, which is a descriptive science. The authors have successfully completed an FDA trial submission for a toxicology test conducted at a CRO and in doing so acquired important knowledge. This article presents a clear picture of such important knowledge from a pathologist's viewpoint.

Specific pathologist responses for Standard for Exchange of Nonclinical Data (SEND)

PubMed Central

Watanabe, Atsushi; Kusuoka, Osamu; Sato, Norihiro; Nakazono, Osamu; Wasko, Michael; Potenta, Daniel; Nakae, Dai; Hatakeyama, Hirofumi; Iwata, Hijiri; Naota, Misaki; Anzai, Takayuki

2017-01-01

The Standard for Exchange of Nonclinical Data (SEND), introduced by the US Food and Drug Administration (FDA), is a scheme for the computerization, electronic application, and screening of preclinical data. Since its establishment, related organizations have been working together to implement SEND. However, it is difficult for individual pharmaceutical companies that often outsource to achieve complete compliance with SEND; hence, the cooperation of contract research organizations (CROs) and SEND Registered Solution Providers (RSPs) is indispensable. In SEND, most data, including those on pathology findings, are converted into controlled terminology (CT), but it is not a simple process to convert findings or levels of severity in the field of pathology, which is a descriptive science. The authors have successfully completed an FDA trial submission for a toxicology test conducted at a CRO and in doing so acquired important knowledge. This article presents a clear picture of such important knowledge from a pathologist’s viewpoint. PMID:28798527

Pentamidine Injection

MedlinePlus

... 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).

75 FR 57279 - Risk Communication Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Committee will hear and discuss developments in FDA's ongoing communications programs, such as FDA's...

NIEHS/FDA CLARITY-BPA research program update.

PubMed

Heindel, Jerrold J; Newbold, Retha R; Bucher, John R; Camacho, Luísa; Delclos, K Barry; Lewis, Sherry M; Vanlandingham, Michelle; Churchwell, Mona I; Twaddle, Nathan C; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A; Flaws, Jodi; Howard, Paul C; Walker, Nigel J; Zoeller, R Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T

2015-12-01

Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. Published by Elsevier Inc.

NIEHS/FDA CLARITY-BPA research program update

PubMed Central

Heindel, Jerrold J.; Newbold, Retha R.; Bucher, John R.; Camacho, Luísa; Delclos, K. Barry; Lewis, Sherry M.; Vanlandingham, Michelle; Churchwell, Mona I.; Twaddle, Nathan C.; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A.; Flaws, Jodi; Howard, Paul C.; Walker, Nigel J.; Zoeller, R. Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T.

2016-01-01

Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. PMID:26232693

40 CFR 264.99 - Compliance monitoring program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... be based on a compliance monitoring program developed to meet the requirements of this section. (i... 40 Protection of Environment 26 2011-07-01 2011-07-01 false Compliance monitoring program. 264.99... Releases From Solid Waste Management Units § 264.99 Compliance monitoring program. An owner or operator...

New technology in electrophysiology: FDA process and perspective.

PubMed

Selzman, Kimberly A; Fellman, Mark; Farb, Andrew; de Del Castillo, Sergio; Zuckerman, Bram

2016-10-01

The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.

Using the OIG model compliance programs to fight fraud.

PubMed

Lovitky, Jeffrey A; Ahern, Jack

2002-03-01

Many healthcare organizations already have implemented compliance programs for their facilities. However, in light of recent fines and continued scrutiny of such programs by the HHS Office of Inspector General (OIG), healthcare organizations should consider reviewing their current programs against the OIG's relevant model compliance program. Although healthcare organizations are not required to adhere strictly to OIG's model programs, they would benefit from ensuring that their programs meet all the OIG's requirements. The common, minimum elements suggested by the OIG model programs include development and distribution of written compliance policies, the designation of a chief compliance officer to manage the program, the development of a corrective action and enforcement system, and the use of audits to monitor compliance. Using these models as guides, healthcare organizations should be better able to avoid the possibility of fraud and abuse within their organizations.

Fault detection and accommodation testing on an F100 engine in an F-15 airplane

NASA Technical Reports Server (NTRS)

Myers, L. P.; Baer-Riedhart, J. L.; Maxwell, M. D.

1985-01-01

The fault detection and accommodation (FDA) methodology for digital engine-control systems may range from simple comparisons of redundant parameters to the more complex and sophisticated observer models of the entire engine system. Evaluations of the various FDA schemes are done using analytical methods, simulation, and limited-altitude-facility testing. Flight testing of the FDA logic has been minimal because of the difficulty of inducing realistic faults in flight. A flight program was conducted to evaluate the fault detection and accommodation capability of a digital electronic engine control in an F-15 aircraft. The objective of the flight program was to induce selected faults and evaluate the resulting actions of the digital engine controller. Comparisons were made between the flight results and predictions. Several anomalies were found in flight and during the ground test. Simulation results showed that the inducement of dual pressure failures was not feasible since the FDA logic was not designed to accommodate these types of failures.

FDA pregnancy risk categories and the CPS

PubMed Central

Law, Ruth; Bozzo, Pina; Koren, Gideon; Einarson, Adrienne

2010-01-01

ABSTRACT QUESTION My patient is taking a medication for a chronic condition and has just found out that she is 6 weeks pregnant. The US Food and Drug Administration (FDA) has assigned this medication to pregnancy risk category D, and the Compendium of Pharmaceuticals and Specialties provides no additional data. How should I interpret this information, and how does the Motherisk Program evaluate the safety or risks of drug use in pregnancy? ANSWER Pregnancy safety data provided by the FDA pregnancy risk categories and the Compendium of Pharmaceuticals and Specialties are insufficient to guide clinical decisions on how to proceed with a pregnancy following exposure to a category D medication. The Motherisk Program creates peer-reviewed statements derived from the primary literature, and we examine fetal outcomes as well as the risk-benefit profile of maternal treatment when evaluating the safety of medication use in pregnancy. The FDA announced in May 2008 that it is dropping its pregnancy risk categories and adopting a method similar to the one we use at Motherisk. PMID:20228306

76 FR 60837 - Federal Acquisition Regulation; Information Collection; Contractor Business Ethics Compliance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

...; Information Collection; Contractor Business Ethics Compliance Program and Disclosure Requirements AGENCIES... concerning contractor business ethics compliance program and disclosure requirements. Public comments are... Collection 9000- 0164, Contractor Business Ethics Compliance Program and Disclosure Requirements, by any of...

76 FR 37353 - Federal Acquisition Regulation; Submission for OMB Review; Contractor Business Ethics Compliance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-27

...; Submission for OMB Review; Contractor Business Ethics Compliance Program and Disclosure Requirements AGENCIES... contractor business ethics compliance program and disclosure requirements. Public comments are particularly... Information Collection 9000- 0164, Contractor Business Ethics Compliance Program and Disclosure Requirements...

Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease.

PubMed

Boyiadzis, Michael M; Kirkwood, John M; Marshall, John L; Pritchard, Colin C; Azad, Nilofer S; Gulley, James L

2018-05-14

The U.S. Food and Drug Administration (FDA) recently approved pembrolizumab, an anti- programmed cell death protein 1 cancer immunotherapeutic, for use in advanced solid tumors in patients with the microsatellite-high/DNA mismatch repair-deficient biomarker. This is the first example of a tissue-agnostic FDA approval of a treatment based on a patient's tumor biomarker status, rather than on tumor histology. Here we discuss key issues and implications arising from the biomarker-based disease classification implied by this historic approval.

Desmopressin Nasal

MedlinePlus

... you experience any unusual problems while using this medication.If you experience a serious side effect, you or your doctor 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).

Current and future policies regarding laboratory animal welfare.

PubMed

Rozmiarek, H

1987-02-01

Laboratory animal welfare has made tremendous strides in recent years. The first laboratory animal welfare law was not enacted until 1966, and laboratory animal medicine as a specialty did not even exist until the 1960s. The AAALAC accreditation program has stimulated improvements in accredited institutions, and the FDA and EPA Good Laboratory Practices Acts had a major impact on industry in the 1970s, but the most visible impact upon academic institutions was made by NIH enforcing their Policy in the 1980s by suspending funding to several programs and institutions. The Association of American Medical Colleges and the Association of American Universities jointly published Recommendations for Governance and Management of Institutional Animal Resources in October 1985, following very closely the provisions of NIH and the Guide. Animal rights groups have even contributed toward the improvement of animal welfare policies by their recent flurry of demonstrations, thefts, and vandalism. The end result has been an impressively rapid upgrading and standardization of animal care and use policies and programs at all types of institutions that use animals in their work. Most major institutions now have qualified and credentialed laboratory animal medicine specialists directing their programs, conscientious and responsive animal care and use committees overseeing and evaluating animal welfare, and qualified, well-trained animal care staff and investigators. Institutions that do not meet these standards undergo great pressure from the USDA, NIH, their peers, and the public to bring their programs into compliance quickly and appropriately.(ABSTRACT TRUNCATED AT 250 WORDS)

Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.

PubMed

Klonoff, David C; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A; Arreaza-Rubin, Guillermo; Burk, Robert D; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W

2016-05-01

Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled "Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program" is attached as supplementary material. This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. © 2015 Diabetes Technology Society.

Clean Air Markets - Compliance Query Wizard

EPA Pesticide Factsheets

The Compliance Query Wizard is part of a suite of Clean Air Markets-related tools that are accessible at http://ampd.epa.gov/ampd/. The Compliance module provides final compliance results. Using the Compliance Query Wizard, the user can find compliance information associated with specific programs, facilities, states or time frames. Quick Reports and Prepackaged Datasets are also available for data that are commonly requested. Final compliance results are available for all years since 1995 for the Acid Rain Program and for the various NOx trading programs EPA has operated since 1999.EPA's Clean Air Markets Division (CAMD) includes several market-based regulatory programs designed to improve air quality and ecosystems. The most well-known of these programs are EPA's Acid Rain Program and the NOx Programs, which reduce emissions of sulfur dioxide (SO2) and nitrogen oxides (NOx)-compounds that adversely affect air quality, the environment, and public health. CAMD also plays an integral role in the development and implementation of the Clean Air Interstate Rule (CAIR).

Environmental Compliance Assessment Management Program (ECAMP) - U.S. Fish and Wildlife Service (FWS)

DTIC Science & Technology

1994-06-01

and Wildlife Service, began research on the Environmental Compliance Assessment and Management Program (ECAMP). The concept was to combine Code of ... The number of environmental laws and regulations have continued to grow in the United States and worldwide, making compliance with these regulations...Service has adopted an environmental compliance program that identifies compliance problems before they are cited as violations by the U.S

Measuring User Compliance and Cost Effectiveness of Safe Drinking Water Programs: A Cluster-Randomized Study of Household Ultraviolet Disinfection in Rural Mexico.

PubMed

Reygadas, Fermín; Gruber, Joshua S; Dreizler, Lindsay; Nelson, Kara L; Ray, Isha

2018-03-01

Low adoption and compliance levels for household water treatment and safe storage (HWTS) technologies have made it challenging for these systems to achieve measurable health benefits in the developing world. User compliance remains an inconsistently defined and poorly understood feature of HWTS programs. In this article, we develop a comprehensive approach to understanding HWTS compliance. First, our Safe Drinking Water Compliance Framework disaggregates and measures the components of compliance from initial adoption of the HWTS to exclusive consumption of treated water. We apply this framework to an ultraviolet (UV)-based safe water system in a cluster-randomized controlled trial in rural Mexico. Second, we evaluate a no-frills (or "Basic") variant of the program as well as an improved (or "Enhanced") variant, to test if subtle changes in the user interface of HWTS programs could improve compliance. Finally, we perform a full-cost analysis of both variants to assess their cost effectiveness (CE) in achieving compliance. We define "compliance" strictly as the habit of consuming safe water. We find that compliance was significantly higher in the groups where the UV program variants were rolled out than in the control groups. The Enhanced variant performed better immediately postintervention than the Basic, but compliance (and thus CE) degraded with time such that no effective difference remained between the two versions of the program.

OpenFDA: an innovative platform providing access to a wealth of FDA’s publicly available data

PubMed Central

Kass-Hout, Taha A; Mohebbi, Matthew; Nelsen, Hans; Baker, Adam; Levine, Jonathan; Johanson, Elaine; Bright, Roselie A

2016-01-01

Objective 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). Materials and Methods 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. Results 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. Conclusion With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products. PMID:26644398

75 FR 1099 - Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-08

... Laundering Compliance Program) and adopt new Rule 3310--NYSE Amex Equities (Anti-Money Laundering Compliance... amendments, NASD Rule 3011 (Anti- Money Laundering Compliance Program) and related Interpretive Material NASD IM-3011-1 and 3011-2 as consolidated FINRA Rule 3310 (Anti-Money Laundering Compliance Program), and...

78 FR 57857 - Medicare and Medicaid Programs; Application from the Compliance Team for Initial CMS-Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-20

...] Medicare and Medicaid Programs; Application from the Compliance Team for Initial CMS-Approval of its Rural... Compliance Team for initial recognition as a national accrediting organization for rural health clinics (RHCs... Compliance Team's request for initial CMS approval of its RHC accreditation program. This notice also...

Human factors and the FDA's goals: improved medical device design.

PubMed

Burlington, D B

1996-01-01

The Food and Drug Administration's new human factors design requirements for medical devices were previewed by the director of the FDA's Center for Devices and Radiological Health (CDRH) at AAMI/FDA's Human Factors in Medical Devices Conference held in September 1995. Director Bruce Burlington, MD, said the FDA plans to take a closer look at how new medical devices are designed to ensure proper attention has been paid to human error prevention. As a medical practitioner who has witnessed use-related deaths and injuries, Burlington stressed the importance of the medical community's reporting use errors as they occur and manufacturers' creating easy-to-use labeling and packaging. He also called for simplicity and quality of design in medical products, and asked for a consolidated effort of all professionals involved in human factors issues to help implement and further the FDA's new human factors program. An edited version of his presentation appears here.

Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries

PubMed Central

Anzai, Takayuki; Kaminishi, Masamichi; Sato, Keizo; Kaufman, Laura; Iwata, Hijiri; Nakae, Dai

2015-01-01

The Standard for the Exchange of Nonclinical Data (SEND), adopted by the US FDA, is part of a set of regulations and guidances requiring the submission of standardized electronic study data for nonclinical and clinical data submissions. SEND is the nonclinical implementation of SDTM (Study Data Tabulation Model), the standard electronic format for clinical regulatory submissions to FDA. SEND, SDTM, and the associated Controlled Terminology have been developed by CDISC (Clinical Data Interchange Standards Consortium). In order to successfully implement SEND, interdisciplinary contributions between sponsors and CROs, need a model for task allocation. This is being undertaken by the Pharmaceutical Users Software Exchange (PhUSE). Because SEND is currently the preferred submission format of the US FDA only and will become required by it starting in December 2016, only American academic societies and companies are actively involved. An exception to this is the INHAND initiative, which leads the way in standardizing terminology for toxicological pathology. On the other hand, international globalization of other clinical and nonclinical practices is not feasible because there are substantial differences between the US and non-US countries in CRO involvement in drug development. Thus, non-US countries must consider and develop approaches to SEND that meet their needs. This paper summarizes the activities of the major organizations involved in SEND development and implementation, discusses the effective use of SEND, and details a compliance scheme (research material of the Showa University School of Medicine) illustrating how pharmaceutical companies can complete a large amount of work up to an FDA application with the effective utilization of CROs and solution providers. PMID:26028814

76 FR 79195 - Animal Drug User Fee Act; Reopening of the Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0656] Animal Drug User Fee Act; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS... notice, FDA requested comments on the Animal Drug User Fee Act (ADUFA) program to date and solicited...

75 FR 54343 - Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Blood...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0436... That Collect Whole Blood and Blood Components AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) is...

78 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... a more transparent process by increasing awareness and knowledge of expanded access programs and the... regulations. Consistent with the goal of making expanded access processes more transparent, FDA is providing... (IRB) review and approval required for individual patient expanded access?'' In the draft guidance, FDA...

Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol

PubMed Central

Klonoff, David C.; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A.; Arreaza-Rubin, Guillermo; Burk, Robert D.; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B.; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W.

2015-01-01

Background: Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. Methods: The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. Results: A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled “Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program” is attached as supplementary material. Conclusion: This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. PMID:26481642

Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

PubMed

Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

2015-06-01

Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

Your business in court: 2009-2010.

PubMed

Reiss, John B; Hall, Christopher R; Wartman, Gregory J

2011-01-01

During this period, FDA focused considerable effort on its transparency initiative, which is likely to continue into the coming year, as well as continuing to ramp up its enforcement activities, as we predicted last year. The scope of the agency's ability to pre-empt state laws in product liability litigation involving pharmaceutical products still is developing post-Levine, and we are likely to see new decisions in the coming year. Fraud and abuse enforcement still is a major factor facing the industry, with the added threat of personal exposure to criminal sentences, fines and debarment from participation in federal and state programs under the Responsible Corporate Officer doctrine, or under the authorities exercised by the Department of Health and Human Services Office of the Inspector General. Consequently, it is increasingly important that senior corporate officers ensure active oversight of an effective compliance program which should mitigate these risks. The Federal Trade Commission continues to battle consumer fraud, particularly respecting weight loss programs, and it appears to be fighting a losing battle in its effort to prevent "reverse" payments to generic manufacturers by Innovator Manufacturers to delay the introduction of generics to the market. The Securities and Exchange Commission continues to be actively enforcing the Foreign Corrupt Practices Act. The Supreme Court gave shareholders more leeway in bringing stockholder suits in situations where a company conceals information that, if revealed, could have a negative effect on stock prices.

Process improvement program evolves into compliance program at an integrated delivery system.

PubMed

Tyk, R C; Hylton, P G

1998-09-01

An integrated delivery system discovered questionable practices when it undertook a process-improvement initiative for its revenue-to-cash cycle. These discoveries served as a wake-up call to the organization that it needed to develop a comprehensive corporate compliance program. The organization engaged legal counsel to help it establish such a program. A corporate compliance officer was hired, and a compliance committee was set up. They worked with counsel to develop the structure and substance of the program and establish a corporate code of conduct that became a part of the organization's policies and procedures. Teams were formed in various areas of the organization to review compliance-related activities and suggest improvements. Clinical and nonclinical staff attended mandatory educational sessions about the program. By approaching compliance systematically, the organization has put itself in an excellent position to avoid fraudulent and abusive activities- and the government scrutiny they invite.

New Advantage 24 contraceptive gel claims 24-hour effectiveness. But proposed FDA rule could put N-9 products to the test.

PubMed

1995-04-01

Advantage 24 is a new contraceptive gel that makes use of bioadhesive technology to offer 24 hours of protection relying on the spermicide nonoxynol-9 (N-9) in lower concentrations. If a proposed US Food and Drug Administration (FDA) rule is enforced N-9 may be examined closely. The manufacturer, Whitehall-Robins Healthcare in New Jersey, stopped production of the Today contraceptive sponge because of the costs of complying with FDA standards. The Advantage 24 gel costs twice as much as the sponge. It is made in Switzerland and distributed by an Illinois company. Any vaginal contraceptive containing N-9 would be approved by the FDA as long as it complied with guidelines laid down in an FDA monograph. However, the registration of the gel could not be confirmed. The product uses a bioadhesive technology concept that natural substances adhere to epithelial and mucosal tissues in the body. Polycarbofil is mixed with water, N-9, and mineral oil to create an emulsion that allows for a time-release mechanism, but at any given time only 2 mg of N-9 is available to kill sperm. The final formula for Advantage 24 is 52.5 mg per dose. Too much N-9 can be toxic, as demonstrated by the Today sponge, which contained 1000 mg of N-9. In Kenya prostitutes using it frequently experienced 3 times as many genital lesions as those using a placebo. A study of Advantage 24 by a Miami laboratory involved 250 women, 22-45 years old, who had had prior tubal ligations. When the gel was applied 15-30 minutes before intercourse the efficacy rate was 98%; it was 91% for those applying it 12 hours before; and it was 86% when the gel was applied 24 hours ahead of time. FDA compliance officers are intrigued about the claim that the gel lasts 24 hours. However, if the claim is held up by research data, women will have an easily available, portable, efficient, aesthetic, and highly effective contraceptive.

Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.

PubMed

Heneghan, Carl J; Goldacre, Ben; Onakpoya, Igho; Aronson, Jeffrey K; Jefferson, Tom; Pluddemann, Annette; Mahtani, Kamal R

2017-12-06

Transvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms. We used FDA databases to determine the evidence for approval of transvaginal mesh. To create a 'family tree' of device equivalence, we used the 510(k) regulatory approval of the 1985 Mersilene Mesh (Ethicon) and the 1996 ProteGen Sling (Boston Scientific), searched for all subsequently related device approvals, and for the first published randomised trial evidence. We assessed compliance with all FDA 522 orders issued in 2012 requiring postmarketing surveillance studies. We found 61 devices whose approval ultimately relied on claimed equivalence to the Mersilene Mesh and the ProteGen Sling. We found no clinical trials evidence for these 61 devices at the time of approval. Publication of randomised clinical trials occurred at a median of 5 years after device approval (range 1-14 years). Analysis of 119 FDA 522 orders revealed that in 79 (66%) the manufacturer ceased market distribution of the device, and in 26 (22%) the manufacturer had changed the indication. Only seven studies (six cohorts and new randomised controlled trial) covering 11 orders were recruiting participants (none had reported outcomes). Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years. Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Tanning facility use: are we exceeding Food and Drug Administration limits?

PubMed

Hornung, Robin L; Magee, Kristin H; Lee, Willie J; Hansen, Lori A; Hsieh, Yi-Ching

2003-10-01

The US Food and Drug Administration (FDA) recommends exposure limits for tanning bed use. Tanning patrons may not be following these recommendations and may be overexposed to damaging ultraviolet radiation (UV). This study was conducted to assess tanning patrons' adherence to FDA-recommended exposure limits and to measure the amount of UVA and UVB radiation emitted by tanning beds. A community-based survey was administered during routine state inspections of North Carolina tanning facilities (n = 50). At each facility, patron records were randomly selected (n = 483) for a survey of exposure records, and UVA and UVB outputs were measured for each tanning bed. The recommended limits were exceeded by 95% of patrons, and 33% of patrons began tanning at the maximum doses recommended for maintenance tanning. Average tanning bed output was 192.1 W/m(2) UVA and 0.35 W/m(2) erythemally weighted UVB. Interventions for tanning bed operators and patrons are needed to increase compliance with federally recommended exposure limits.

The regulation of mobile medical applications.

PubMed

Yetisen, Ali Kemal; Martinez-Hurtado, J L; da Cruz Vasconcellos, Fernando; Simsekler, M C Emre; Akram, Muhammad Safwan; Lowe, Christopher R

2014-03-07

The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications and protect consumers by minimising the risks associated with their unintended use. This guidance distinguishes between the subset of mobile medical apps which may be subject to regulation and those that are not. The marketing claims of the application determine the intent. Areas of concern include compliance with regular updates of the operating systems and of the mobile medical apps themselves. In this article, we explain the essence of this FDA guidance by providing examples and evaluating the impact on academia, industry and other key stakeholders, such as patients and clinicians. Our assessment indicates that awareness and incorporation of the guidelines into product development can hasten the commercialisation and market entry process. Furthermore, potential obstacles have been discussed and directions for future development suggested.

Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States

PubMed Central

Lassman, Scott M; Shopshear, Olivia M; Jazic, Ina; Ulrich, Jocelyn; Francer, Jeffrey

2017-01-01

Objective To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open which reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies. Design We performed a reassessment of the data reported in Miller et al to evaluate whether statutory compliance analyses and conclusions were valid. Data sources Information from the Dryad Digital Repository, ClinicalTrials.gov, Drugs@FDA and direct communications with sponsors. Main outcome measures Compliance with the clinical trial registration and results reporting requirements under the Food and Drug Administration Amendments Act (FDAAA). Results Industry compliance with FDAAA disclosure requirements was notably higher than reported by Miller et al. Among trials subject to FDAAA, Miller et al reported that, per drug, a median of 67% (middle 50% range: 0%–100%) of trials fully complied with registration and results reporting requirements. On reanalysis of the data, we found that a median of 100% (middle 50% range: 93%–100%) of clinical trials for a particular drug fully complied with the law. When looking at overall compliance at the trial level, our reassessment yields 94% timely registration and 90% timely results reporting among the 49 eligible trials, and an overall FDAAA compliance rate of 86%. Conclusions The claim by Miller et al that industry compliance is below legal standards is based on an analysis that relies on an incomplete dataset and an interpretation of FDAAA that requires disclosure of study results for drugs that have not yet been approved for any indication. On reanalysis using a different interpretation of FDAAA that focuses on whether results were disclosed within 30 days of drug approval, we found that industry compliance with US statutory disclosure requirements for the 15 reviewed drugs was consistently high. PMID:28942418

77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-27

... costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements... critical and measurable enhancements to FDA's generic drugs program. GDUFA establishes fees for abbreviated... current thinking on generic drug user fee amendments of 2012. It does not create or confer any rights for...

78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-10

... public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and... assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA...). The draft guidance, when finalized, will represent the Agency's current thinking on ``Generic Drug...

Piloting the future: Results from a pilot study for changes in the animal sampling program for the national antibiotic resistance monitoring system (NARMS)

USDA-ARS?s Scientific Manuscript database

A well recognized monitoring system for antimicrobial resistance in the U. S. is the National Antimicrobial Resistance Monitoring System (NARMS). It was established in 1996 among the Food and Drug Administration (FDA), USDA, and Centers for Disease Control and Prevention (CDC). FDA coordinates the ...

Clinical trials of boron neutron capture therapy [in humans] [at Beth Israel Deaconess Medical Center][at Brookhaven National Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wallace, Christine

2001-05-29

Assessment of research records of Boron Neutron Capture Therapy was conducted at Brookhaven National Laboratory and Beth Israel Deaconess Medical Center using the Code of Federal Regulations, FDA Regulations and Good Clinical Practice Guidelines. Clinical data were collected from subjects' research charts, and differences in conduct of studies at both centers were examined. Records maintained at Brookhaven National Laboratory were not in compliance with regulatory standards. Beth Israel's records followed federal regulations. Deficiencies discovered at both sites are discussed in the reports.

Clarification of radiation-control regulations for diagnostic x-ray equipment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

The Office of Compliance and Surveillance of the Center for Devices and Radiological Health (CDRH) has received many requests for interpretation of the Federal regulations that relate to diagnostic x-ray equipment. Responses to these requests were originally issued as FDA Compliance Policy Guides, industry-wide letters, and letters to individuals. The document is a compilation of those responses that remain applicable. Guides or opinions that have been withdrawn or are now obsolete because they have been incorporated into the regulations are not included. The document consists of two sections: the General section, which contains information of a general nature; and themore » Specific section, which contains information specific to particular sections of the Federal Performance Standard for Diagnostic X-ray Equipment (21 CFR 1020.30-32). When the term 'Revised Language' appears in an item heading, it indicates English grammar correction; the term 'Revised' indicates an updated version of the original clarification.« less

13 CFR 120.180 - Lender and CDC compliance with Loan Program Requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Lender and CDC compliance with... Program Requirements § 120.180 Lender and CDC compliance with Loan Program Requirements. Lenders must... are revised from time to time. CDCs must comply and maintain familiarity with Loan Program...

13 CFR 120.180 - Lender and CDC compliance with Loan Program Requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Lender and CDC compliance with... Program Requirements § 120.180 Lender and CDC compliance with Loan Program Requirements. Lenders must... are revised from time to time. CDCs must comply and maintain familiarity with Loan Program...

13 CFR 120.180 - Lender and CDC compliance with Loan Program Requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Lender and CDC compliance with... Program Requirements § 120.180 Lender and CDC compliance with Loan Program Requirements. Lenders must... are revised from time to time. CDCs must comply and maintain familiarity with Loan Program...

13 CFR 120.180 - Lender and CDC compliance with Loan Program Requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Lender and CDC compliance with... Program Requirements § 120.180 Lender and CDC compliance with Loan Program Requirements. Lenders must... are revised from time to time. CDCs must comply and maintain familiarity with Loan Program...

13 CFR 120.180 - Lender and CDC compliance with Loan Program Requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Lender and CDC compliance with... Program Requirements § 120.180 Lender and CDC compliance with Loan Program Requirements. Lenders must... are revised from time to time. CDCs must comply and maintain familiarity with Loan Program...

The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) Program - Current Status and Future Direction.

PubMed

Wu, Jasmanda; Juhaeri, Juhaeri

2016-12-01

The US Food and Drug Administration (FDA) Amendments Act of 2007 granted the FDA new authorities to enhance drug safety by requiring application holders to submit a proposed Risk Evaluation and Mitigation Strategy (REMS). A REMS is a required risk management plan that uses tools beyond the package insert. REMS elements may include a medication guide and patient package insert for patients and a communication plan focused on health care professionals. Elements to assure safe use (ETASUs) are put in place to mitigate a specific known serious risk when other less restrictive elements of a REMS are not sufficient to mitigate such risk. An implementation system is required for an REMS that includes the ETASUs. With approximately eight years of experience with REMS programs, many health care settings have created systems to manage REMS and also to integrate REMS into their practice settings. At the same time, there are issues associated with the development and implementation of REMS. In 2011, FDA created the REMS Integration Initiative to develop guidance on how to apply statutory criteria to determine when a REMS is required, to improve standardization and assessment of REMS, and to improve integration of REMS into the existing healthcare system. A key component of the REMS Integration Initiative is stakeholder outreach to better understand how existing REMS programs are working and to identify opportunities for improvement. This review attempts to share our company's experience with the REMS program, and to provide updates on FDA's efforts to improve REMS communication, to standardize REMS process, to reduce REMS program burdens and to build a common REMS platform. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

10 CFR 1040.101 - Compliance reviews.

Code of Federal Regulations, 2011 CFR

2011-01-01

... DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES Program Monitoring § 1040.101 Compliance reviews. (a) The Director shall periodically conduct compliance... of: (1) The practices to be reviewed; (2) The programs or activities affected by the review; (3) The...

10 CFR 1040.101 - Compliance reviews.

Code of Federal Regulations, 2013 CFR

2013-01-01

... DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES Program Monitoring § 1040.101 Compliance reviews. (a) The Director shall periodically conduct compliance... of: (1) The practices to be reviewed; (2) The programs or activities affected by the review; (3) The...

10 CFR 1040.101 - Compliance reviews.

Code of Federal Regulations, 2012 CFR

2012-01-01

... DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES Program Monitoring § 1040.101 Compliance reviews. (a) The Director shall periodically conduct compliance... of: (1) The practices to be reviewed; (2) The programs or activities affected by the review; (3) The...

10 CFR 1040.101 - Compliance reviews.

Code of Federal Regulations, 2014 CFR

2014-01-01

... DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES Program Monitoring § 1040.101 Compliance reviews. (a) The Director shall periodically conduct compliance... of: (1) The practices to be reviewed; (2) The programs or activities affected by the review; (3) The...

10 CFR 1040.101 - Compliance reviews.

Code of Federal Regulations, 2010 CFR

2010-01-01

... DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES Program Monitoring § 1040.101 Compliance reviews. (a) The Director shall periodically conduct compliance... of: (1) The practices to be reviewed; (2) The programs or activities affected by the review; (3) The...

The Prescription Drug User Fee Act: Cause for Concern?

PubMed

Gabay, Michael

2018-04-01

The Prescription Drug User Fee Act (PDUFA) was originally enacted into law in 1992. PDUFA provides the Food and Drug Administration (FDA) with needed revenue in the form of various fees paid by drug and biologic manufacturers. The FDA utilizes this revenue to streamline the review and approval process for medications. Since the enactment of PDUFA, the median approval time for priority new drug applications and biologics license applications has reduced significantly. The FDA views PDUFA as a successful program that provides a consistent revenue stream to the agency, improves access to medications for patients, and allows industry to have a more predictable product review timeline. However, critics of PDUFA cite concerns including the potential for a lack of FDA independence and medication safety issues involving drugs approved after the existence of PDUFA.

Blueprint for prescriber continuing education program.

PubMed

2012-06-01

On October 25, 2011, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) posted online this Blueprint for Prescriber Continuing Education, labeled "final," relating to extended-release and long-acting opioids. The pending FDA Risk Evaluation Management Strategy (REMS) requires prescriber education. This document provides guidance to sponsors of these dosage forms in developing the prescvriber education component of their REMS. This report was posted online by the federal agency on October 25, 2011 at: http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf. It is in the public domain.

75 FR 57410 - Energy Conservation Program: Certification, Compliance, and Enforcement for Consumer Products and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-21

..., regarding the Energy Conservation Program: Certification, Compliance, and Enforcement for Consumer Products... [Docket No. EERE-2010-BT-CE-0014] RIN 1904-AC23 Energy Conservation Program: Certification, Compliance, and Enforcement for Consumer Products and Commercial and Industrial Equipment; Correction AGENCY...

FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

Cancer.gov

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

75 FR 27182 - Energy Conservation Program: Web-Based Compliance and Certification Management System

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-14

... Conservation Program: Web-Based Compliance and Certification Management System AGENCY: Office of Energy... certification reports to the Department of Energy (DOE) through an electronic Web-based tool, the Compliance and... following means: 1. Compliance and Certification Management System (CCMS)--via the Web portal: http...

30 CFR 773.11 - Review of compliance history.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

30 CFR 773.11 - Review of compliance history.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

30 CFR 773.11 - Review of compliance history.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

30 CFR 773.11 - Review of compliance history.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

30 CFR 773.11 - Review of compliance history.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

40 CFR 68.58 - Compliance audits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Compliance audits. 68.58 Section 68.58... ACCIDENT PREVENTION PROVISIONS Program 2 Prevention Program § 68.58 Compliance audits. (a) The owner or... are being followed. (b) The compliance audit shall be conducted by at least one person knowledgeable...

40 CFR 68.79 - Compliance audits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Compliance audits. 68.79 Section 68.79... ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.79 Compliance audits. (a) The owner or... are being followed. (b) The compliance audit shall be conducted by at least one person knowledgeable...

10 CFR 851.13 - Compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Compliance. 851.13 Section 851.13 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Program Requirements § 851.13 Compliance. (a) Contractors must achieve compliance with all the requirements of Subpart C of this part, and their approved worker safety...

FMCSA safety program effectiveness measurement compliance review effectiveness model results for carriers with compliance reviews in fiscal year 2009 : [analysis brief].

DOT National Transportation Integrated Search

2014-04-01

This Analysis Brief documents the methodology and results from the Compliance Review Effectiveness Model (CREM) for carriers receiving CRs in fiscal year (FY) 2009. The model measures the effectiveness of the compliance review (CR) program, one of th...

10 CFR 851.13 - Compliance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Compliance. 851.13 Section 851.13 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Program Requirements § 851.13 Compliance. (a) Contractors must achieve compliance with all the requirements of Subpart C of this part, and their approved worker safety...

Regulatory aspects of noninvasive glucose measurements.

PubMed

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.

IVGEN Post Flight Analysis

NASA Technical Reports Server (NTRS)

Mcquillen, John; Brown, Dan; Hussey, Sam; Zoldak, John

2014-01-01

The Intravenous Fluid Generation (IVGEN) Experiment was a technology demonstration experiment that purified ISS potable water, mixed it with salt, and transferred it through a sterilizing filter. On-orbit performance was verified as appropriate and two 1.5 l bags of normal saline solution were returned to earth for post-flight testing by a FDA certified laboratory for compliance with United States Pharmacopiea (USP) standards. Salt concentration deviated from required values and an analysis identified probable causes. Current efforts are focused on Total Organic Content (TOC) testing, and shelf life.The Intravenous Fluid Generation (IVGEN) Experiment demonstrated the purification of ISS potable water, the mixing of the purified water with sodium chloride, and sterilization of the solution via membrane filtration. On-orbit performance was monitored where feasible and two 1.5-liter bags of normal saline solution were returned to earth for post-flight testing by a FDA-registered laboratory for compliance with United States Pharmacopeia (USP)standards [1]. Current efforts have been focused on challenge testing with identified [2] impurities (total organic-carbon), and shelf life testing. The challenge testing flowed known concentrations of contaminants through the IVGEN deionizing cartridge and membrane filters to test their effectiveness. One finding was that the filters and DI-resin themselves contribute to the contaminant load during initial startup, suggesting that the first 100 ml of fluid be discarded. Shelf life testing is ongoing and involves periodic testing of stored DI cartridges and membrane filters that are capped and sealed in hermetic packages. The testing is conducted at six month intervals measuring conductivity and endotoxins in the effluent. Currently, the packaging technique has been successfully demonstrated for one year of storage testing. The USP standards specifies that the TOC be conducted at point of generation as opposed to point of consumption. Samples were generated and shipped to an FDA facility however, testing determined that the samples failed the TOC specification with most likely due to leaching from the sample container. Shelf life testing is examining packaging techniques and periodic testing of samples of DI cartridges that are capped and sealed in hermetic packages. Periodic testing of the purified water output will be conducted at six month intervals.

76 FR 24761 - Energy Conservation Program: Certification, Compliance, and Enforcement for Consumer Products and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

... Conservation Program: Certification, Compliance, and Enforcement for Consumer Products and Commercial and...) Certification. Each manufacturer, before distributing in commerce any basic model of a covered product or.... EERE-2010-BT-CE-0014] RIN 1904-AC23 Energy Conservation Program: Certification, Compliance, and...

78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

...] International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot... Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and...

Quality assurance in nuclear medicine facilities; availability of final recommendations--FDA. Notice.

PubMed

1985-05-13

The Food and Drug Administration (FDA) is announcing the availability of final recommendations prepared by its Center for Devices and Radiological Health (CDRH) on quality assurance programs in nuclear medicine facilities. The final recommendations include the agency's rationale for the recommendations as well as references that can be used as well as references that can be used as guides in conducting quality control monitoring. These final recommendations are available as a technical report in CDRH's radiation recommendations series. They are intended to encourage and promote the development of voluntary quality assurance programs in nuclear medicine facilities.

Unequal Sized Pupils Due to Escitalopram; Adverse Events to Dietary Supplements Causing Emergency Department Visits; Compulsive Masturbation Due to Pramipexole; Metformin-Induced Lactic Acidosis Masquerading As an Acute Myocardial Infarction.

PubMed

Mancano, Michael A

2016-05-01

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) Med Watch program (800-FDA-1088). If you have reported an interesting, preventable ADR to Med Watch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's Med Watchprogram and Temple University School of Pharmacy. ISMP is an FDA Med Watch partner.

An integrated bioinformatics infrastructure essential for advancing pharmacogenomics and personalized medicine in the context of the FDA's Critical Path Initiative.

PubMed

Tong, Weida; Harris, Stephen C; Fang, Hong; Shi, Leming; Perkins, Roger; Goodsaid, Federico; Frueh, Felix W

2007-01-01

Pharmacogenomics (PGx) is identified in the FDA Critical Path document as a major opportunity for advancing medical product development and personalized medicine. An integrated bioinformatics infrastructure for use in FDA data review is crucial to realize the benefits of PGx for public health. We have developed an integrated bioinformatics tool, called ArrayTrack, for managing, analyzing and interpreting genomic and other biomarker data (e.g. proteomic and metabolomic data). ArrayTrack is a highly flexible and robust software platform, which allows evolving with technological advances and changing user needs. ArrayTrack is used in the routine review of genomic data submitted to the FDA; here, three hypothetical examples of its use in the Voluntary eXploratory Data Submission (VXDS) program are illustrated.: © Published by Elsevier Ltd.

7 CFR Exhibit A to Subpart E of... - Civil Rights Compliance Reviews

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 12 2012-01-01 2012-01-01 false Civil Rights Compliance Reviews A Exhibit A to... OF AGRICULTURE PROGRAM REGULATIONS PROGRAM-RELATED INSTRUCTIONS Civil Rights Compliance Requirements Pt. 1901, Subpt. E, Exh. A Exhibit A to Subpart E of Part 1901—Civil Rights Compliance Reviews To...

7 CFR 1484.74 - How is Cooperator program compliance monitored?

Code of Federal Regulations, 2011 CFR

2011-01-01

... is Cooperator program compliance monitored? (a) The Compliance Review Staff (CRS), FAS, performs... pursuant to § 1550.20(a)(14), FAS will consider the Cooperator's overall marketing budget from year to year...

Evaluation of a continual compliance monitoring program for dapsone in an outpatient Hansen's disease clinic.

PubMed

Fischer, J H; West, D P; Worobec, S M

1986-12-01

Guidelines for the assessment of patient compliance to dapsone were developed and evaluated. The urinary dapsone-to-creatinine (D/C) ratio following standardization by dose, ideal body weight, and time since last dose was used for assessment of compliance. Compliance standards were established in 12 patients of known compliance and confirmed prospectively in nine inpatients on 14 occasions. Compliance increased significantly among outpatients (N = 30) attending the University of Illinois Hansen's Disease Clinic from 47% at base line to 73% at 6 months and 80% at 18 months after establishing the monitoring program. In a subgroup of 18 patients, a similar increase in compliance was observed from 50% to 80%. A good therapeutic response was seen in the subgroup patients who were compliant. A poor therapeutic response was seen in the consistently noncompliant patients. These results demonstrate that use of a continual compliance monitoring program can improve patient drug compliance in an outpatient Hansen's disease clinic.

40 CFR 80.1334 - What are the requirements for early compliance with the gasoline benzene program?

Code of Federal Regulations, 2011 CFR

2011-07-01

... compliance with the gasoline benzene program? 80.1334 Section 80.1334 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGULATION OF FUELS AND FUEL ADDITIVES Gasoline Benzene Hardship Provisions § 80.1334 What are the requirements for early compliance with the gasoline...

40 CFR 80.1334 - What are the requirements for early compliance with the gasoline benzene program?

Code of Federal Regulations, 2010 CFR

2010-07-01

... compliance with the gasoline benzene program? 80.1334 Section 80.1334 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGULATION OF FUELS AND FUEL ADDITIVES Gasoline Benzene Hardship Provisions § 80.1334 What are the requirements for early compliance with the gasoline...

40 CFR 80.1334 - What are the requirements for early compliance with the gasoline benzene program?

Code of Federal Regulations, 2013 CFR

2013-07-01

... compliance with the gasoline benzene program? 80.1334 Section 80.1334 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGULATION OF FUELS AND FUEL ADDITIVES Gasoline Benzene Hardship Provisions § 80.1334 What are the requirements for early compliance with the gasoline...

40 CFR 80.1334 - What are the requirements for early compliance with the gasoline benzene program?

Code of Federal Regulations, 2012 CFR

2012-07-01

... compliance with the gasoline benzene program? 80.1334 Section 80.1334 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGULATION OF FUELS AND FUEL ADDITIVES Gasoline Benzene Hardship Provisions § 80.1334 What are the requirements for early compliance with the gasoline...

40 CFR 80.1334 - What are the requirements for early compliance with the gasoline benzene program?

Code of Federal Regulations, 2014 CFR

2014-07-01

... compliance with the gasoline benzene program? 80.1334 Section 80.1334 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGULATION OF FUELS AND FUEL ADDITIVES Gasoline Benzene Hardship Provisions § 80.1334 What are the requirements for early compliance with the gasoline...

29 CFR 1608.5 - Affirmative action compliance programs under Executive Order No. 11246, as amended.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 4 2011-07-01 2011-07-01 false Affirmative action compliance programs under Executive... EMPLOYMENT OPPORTUNITY COMMISSION AFFIRMATIVE ACTION APPROPRIATE UNDER TITLE VII OF THE CIVIL RIGHTS ACT OF 1964, AS AMENDED § 1608.5 Affirmative action compliance programs under Executive Order No. 11246, as...

29 CFR 1608.5 - Affirmative action compliance programs under Executive Order No. 11246, as amended.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 4 2010-07-01 2010-07-01 false Affirmative action compliance programs under Executive... EMPLOYMENT OPPORTUNITY COMMISSION AFFIRMATIVE ACTION APPROPRIATE UNDER TITLE VII OF THE CIVIL RIGHTS ACT OF 1964, AS AMENDED § 1608.5 Affirmative action compliance programs under Executive Order No. 11246, as...

40 CFR 97.254 - Compliance with CAIR SO2 emissions limitation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Compliance with CAIR SO2 emissions... PROGRAMS (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS CAIR SO2 Allowance Tracking System § 97.254 Compliance with CAIR SO2 emissions limitation. (a) Allowance transfer...

40 CFR 96.254 - Compliance with CAIR SO2 emissions limitation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Compliance with CAIR SO2 emissions... PROGRAMS (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR SO2 Allowance Tracking System § 96.254 Compliance with CAIR SO2 emissions limitation...

40 CFR 745.327 - State or Indian Tribal lead-based paint compliance and enforcement programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false State or Indian Tribal lead-based paint compliance and enforcement programs. 745.327 Section 745.327 Protection of Environment... Tribal lead-based paint compliance and enforcement program must have the technological capability to...

40 CFR 745.327 - State or Indian Tribal lead-based paint compliance and enforcement programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false State or Indian Tribal lead-based paint compliance and enforcement programs. 745.327 Section 745.327 Protection of Environment... Tribal lead-based paint compliance and enforcement program must have the technological capability to...

FDA working to ensure the safety of medical devices used in the pediatric population.

PubMed

Flack, Marilyn Neder; Gross, Thomas P; Reid, Joy Samuels; Mills, Thalia T; Francis, Jacqueline

2012-12-01

Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA. Published by Elsevier Inc.

Health Reports

DTIC Science & Technology

1992-11-01

Food and Drug Recombinant Bovine Growth Hormone: FDA Approval Should Be Withheld Administration Until the Mastitis Issue Is Resolved (Report, Aug. 6...Care: Demonstration Project Concerning Future Structure of Veterans’ Health Program (Testimony, Aug. 11, 1992, GA(Yr-HRD-92-53). Recombinant Bovine ...Growth Hormone: FDA Approval Should Be Withheld Until the Mastitis Issue Is Resolved (Report, Aug. 6, 1992, GAO/PEMD-92-26). Page 10 GAD/RRD-98-38 Health

78 FR 23941 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-23

...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the... 13343), FDA terminated the acceptance of applications into the program and extended the pilot program for the nine accepted sponsors until May 8, 2013. The pilot program will be further extended for the...

The role of healthcare communications agencies in maintaining compliance when working with the pharmaceutical industry and healthcare professionals.

PubMed

Cairns, Angela; Yarker, Yvonne E

2008-05-01

Relationships between the pharmaceutical industry and healthcare professionals continue to drive discussion about the potential for conflicts of interest. Despite greater regulation and oversight, there are still calls for increased transparency and further restrictions on these relationships. Regulatory authorities, the pharmaceutical industry, professional societies, and other interested parties have responded by developing robust guidelines for interactions between the pharmaceutical industry and healthcare professionals. This, in turn, is driving change in the way that healthcare communications agencies work, increasing the need for them to visibly demonstrate processes that ensure their employees comply with relevant laws, regulations, and guidelines. In our group of healthcare communications agencies we have established an internal compliance program and developed a policy that reflects the services we provide, and we recommend that other agencies adopt a similar program. Compliance training, implemented by a nominated compliance team, can be enforced by including compulsory tests for employees who interact with the pharmaceutical industry and healthcare professionals, with annual reassessment. The compliance team also has an important role to play in ensuring ongoing communication and staff education, including awareness of new legal and best practice developments. Management of the compliance program is essential, with clear mechanisms for auditing and evaluation, and the inclusion of compliance adherence in staff performance objectives. A visible framework for handling potential compliance issues should also be developed, with clear definitions of different levels of noncompliance and potential associated consequences. Compliance programs may also include other elements, such as terminology and documentation guidance, so that the program becomes an integral tool used by employees on a daily basis. With a robust internal compliance program, healthcare communication agencies can play a significant role in helping maintain appropriate pharmaceutical industry-healthcare professional relationships in an increasingly regulated and scrutinized environment.

23 CFR 230.401 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Purpose. 230.401 Section 230.401 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CIVIL RIGHTS EXTERNAL PROGRAMS Construction Contract... contract compliance program, including compliance reviews, consolidated compliance reviews, and the...

Unequal Sized Pupils Due to Escitalopram; Adverse Events to Dietary Supplements Causing Emergency Department Visits; Compulsive Masturbation Due to Pramipexole; Metformin-Induced Lactic Acidosis Masquerading As an Acute Myocardial Infarction

PubMed Central

Mancano, Michael A.

2016-01-01

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) Med Watch program (800-FDA-1088). If you have reported an interesting, preventable ADR to Med Watch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's Med Watchprogram and Temple University School of Pharmacy. ISMP is an FDA Med Watch partner. PMID:27303087

10 CFR 1040.102 - Compliance information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Compliance information. 1040.102 Section 1040.102 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES Program Monitoring § 1040.102 Compliance information. (a) Cooperation and assistance. Each responsible...

10 CFR 1040.102 - Compliance information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Compliance information. 1040.102 Section 1040.102 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES Program Monitoring § 1040.102 Compliance information. (a) Cooperation and assistance. Each responsible...

10 CFR 1040.102 - Compliance information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Compliance information. 1040.102 Section 1040.102 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES Program Monitoring § 1040.102 Compliance information. (a) Cooperation and assistance. Each responsible...

10 CFR 1040.102 - Compliance information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Compliance information. 1040.102 Section 1040.102 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES Program Monitoring § 1040.102 Compliance information. (a) Cooperation and assistance. Each responsible...

The 10th Annual Bioassays and Bioanalytical Method Development Conference.

PubMed

Ma, Mark; Tudan, Christopher; Koltchev, Dolly

2015-01-01

The 10th Annual Bioassays and Bioanalytical Method Development Conference was hosted in Boston, MA, USA on 20-22 October 2014. This meeting brought together scientists from the biopharmaceutical and life sciences industries, the regulatory agency and academia to share and discuss current trends in cell-based assays and bioanalysis, challenges and ideas for the future of the bioassays and bioanalytical method development. The experiences associated with new and innovative technologies were evaluated as well as their impact on the current bioassays methodologies and bioanalysis workflow, including quality, feasibility, outsourcing strategies and challenges, productivity and compliance. Several presentations were also provided by members of the US FDA, sharing both scientific and regulatory paradigms including a most recent update on the position of the FDA with specific aspects of the draft Bioanalytical Method Validation guidance following its review of the industry's responses. The meeting was jointly coincided with the 15th Annual Immunogenicity for Biotherapeutics meeting, allowing for attendees to also familiarize themselves with new and emerging approaches to overcome the effect of immunogenicity, in addition to investigative strategies.

24 CFR 266.520 - Program monitoring and compliance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.520 Program monitoring and compliance. HUD will monitor the...

24 CFR 266.520 - Program monitoring and compliance.

Code of Federal Regulations, 2012 CFR

2012-04-01

... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.520 Program monitoring and compliance. HUD will monitor the...

24 CFR 266.520 - Program monitoring and compliance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.520 Program monitoring and compliance. HUD will monitor the...

24 CFR 266.520 - Program monitoring and compliance.

Code of Federal Regulations, 2013 CFR

2013-04-01

... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.520 Program monitoring and compliance. HUD will monitor the...

24 CFR 266.520 - Program monitoring and compliance.

Code of Federal Regulations, 2014 CFR

2014-04-01

... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.520 Program monitoring and compliance. HUD will monitor the...

7 CFR 773.9 - Environmental compliance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 7 2014-01-01 2014-01-01 false Environmental compliance. 773.9 Section 773.9 Agriculture Regulations of the Department of Agriculture (Continued) FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE SPECIAL PROGRAMS SPECIAL APPLE LOAN PROGRAM § 773.9 Environmental compliance. (a) Except as...

7 CFR 773.9 - Environmental compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 7 2010-01-01 2010-01-01 false Environmental compliance. 773.9 Section 773.9 Agriculture Regulations of the Department of Agriculture (Continued) FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE SPECIAL PROGRAMS SPECIAL APPLE LOAN PROGRAM § 773.9 Environmental compliance. (a) Except as...

7 CFR 773.9 - Environmental compliance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 7 2011-01-01 2011-01-01 false Environmental compliance. 773.9 Section 773.9 Agriculture Regulations of the Department of Agriculture (Continued) FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE SPECIAL PROGRAMS SPECIAL APPLE LOAN PROGRAM § 773.9 Environmental compliance. (a) Except as...

75 FR 4474 - Energy Conservation Program: Certification, Compliance, and Enforcement Requirements for Certain...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-28

... titled ``Certification, Compliance, and Enforcement Requirements for Certain Consumer Products and...-AA96 and 1904-AB53 Energy Conservation Program: Certification, Compliance, and Enforcement Requirements for Certain Consumer Products and Commercial and Industrial Equipment; Correction AGENCY: Office of...

Healthy public relations: the FDA's 1930s legislative campaign.

PubMed

Kay, G

2001-01-01

In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more.

Indoor tanning injuries: an evaluation of FDA adverse event reporting data.

PubMed

Dowdy, John C; Sayre, Robert M; Shepherd, James G

2009-08-01

In 1979 the Food and Drug Administration (FDA) designated indoor tanning units would be regulated medical devices and that each must have an exposure timer. In 1985 FDA added a scheduled series of doses designed to allow tanning with little risk of concomitant sunburn. Subsequently FDA/CDRH maintained databases in which medical device associated injuries were reported. The databases, MAUDE and its predecessor MDR, are available online. While these records, in part, are not intended for evaluation of adverse event rates, analysis provides insight into the etiology of UV-related tanning injuries. We compiled 142 records reported for 1985-2006 including 22% noninjury malfunctions. Of the reported injuries approximately 50% resulted from UV exposure, an average of <1/year resulted in hospitalization. At least 36% of the UV-related injuries were attributable to various (user/operator) noncompliance with FDA sunlamp guidance policies. During 1985-1995 there were six times more UV injuries than 1996-2006, presumably reflecting cessation of much mandatory reporting in 1996. Injury reports declined steady from 1997 to 2006. FDA guidance appears most efficacious in injury prevention and we encourage its incorporation into the enforceable performance standard. We also advise that tanning industry professional training programs seek standardization/accreditation of their personnel certifications through recognized accreditation bodies such as ANSI or ISO/IEC.

76 FR 62808 - Pilot Program for Parallel Review of Medical Products

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-11

... voluntary participation in the pilot program, as well as the guiding principles the Agencies intend to... 57045), parallel review is intended to reduce the time between FDA marketing approval and CMS national...

A rational regulatory approach for positron emission tomography imaging probes: from "first in man" to NDA approval and reimbursement.

PubMed

Barrio, Jorge R; Marcus, Carol S; Hung, Joseph C; Keppler, Jennifer S

2004-01-01

We propose a new regulatory approach for positron emission tomography (PET) molecular imaging probes, essential tools in today's medicine. Even though the focus of this paper is on positron-emitting labeled probes, it is also justified to extend this proposed regulatory approach to other diagnostic nuclear medicine radiopharmaceuticals. Key aspects of this proposal include: (1) PET molecular imaging probes would be placed in a "no significant risk" category, similar to that category for devices in current Food and Drug Administration (FDA) regulations, based on overwhelming scientific evidence that demonstrates their faultless safety profile; (2) the FDA-sanctioned Radioactive Drug Research Committee (RDRC) will oversee all diagnostic research with these probes. The newly defined RDRC should approve "first in man" use; supervise a broader spectrum of diagnostic research protocols, including those looking to demonstrate initial efficacy, as well as multicenter clinical trials and the use of molecular imaging probes as a screening tool in drug discovery. The current investigational new drug (IND) mechanism is thus eliminated for these diagnostic probes; (3) when a molecular imaging probe has demonstrated diagnostic efficacy, FDA approval (i.e., NDA) will be sought. The review will be done by a newly constituted Radioactive Drug Advisory Committee (RDAC) composed of experts chosen by the professional societies, who would provide a binding assessment of the adequacy of the safety and efficacy data. When the RDAC recommends its diagnostic use on scientific and medical grounds, the molecular imaging probe becomes FDA approved. After a molecular imaging probe is approved for a diagnostic indication, the existing mechanism to seek reimbursement will be utilized; and (4) the FDA would retain its direct oversight function for traditional manufacturers engaged in commercial distribution of the approved diagnostic molecular imaging probes (i.e., under NDA) to monitor compliance with existing US Pharmacopeia (USP) requirements. With abbreviated and more appropriate regulations, new PET molecular imaging probes for diagnostic use would be then rapidly incorporated into the mainstream diagnostic medicine. Equally importantly, this approach would facilitate the use of molecular imaging in drug discovery and development, which would substantially reduce the costs and time required to bring new therapeutic drugs to market.

40 CFR 76.13 - Compliance and excess emissions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 16 2011-07-01 2011-07-01 false Compliance and excess emissions. 76.13 Section 76.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.13 Compliance and excess emissions...

40 CFR 76.13 - Compliance and excess emissions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 17 2012-07-01 2012-07-01 false Compliance and excess emissions. 76.13 Section 76.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.13 Compliance and excess emissions...

40 CFR 76.13 - Compliance and excess emissions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Compliance and excess emissions. 76.13 Section 76.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.13 Compliance and excess emissions...

40 CFR 76.13 - Compliance and excess emissions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 17 2013-07-01 2013-07-01 false Compliance and excess emissions. 76.13 Section 76.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.13 Compliance and excess emissions...

40 CFR 76.13 - Compliance and excess emissions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 17 2014-07-01 2014-07-01 false Compliance and excess emissions. 76.13 Section 76.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.13 Compliance and excess emissions...

Quality consciousness...auditing for HIPAA Privacy Compliance.

PubMed

LePar, Kathleen

2004-01-01

The Health Insurance Portability and Accountability Act (HIPAA) privacy deadline has passed. Now it is essential to comply with the regulations. The stakes are high; therefore, a HIPAA Privacy Compliance Program must be part of an organization's quality initiatives. This article provides guidelines for the challenges of continual program improvement, successful cultural change, and effective monitoring of the existing program. Healthcare organizations will attain compliance goals through internal audits on the processes, policies, and training efforts of their HIPAA program.

Effective health care corporate compliance.

PubMed

Saum, T B; Byassee, J

2000-01-01

The pace and intensity of oversight and investigation of health care organizations has greatly increased at all levels. Well run organizations with ethical management committed to following all laws and regulations are still at risk for compliance violations and punitive penalties. Under the Federal Sentencing Guidelines, organizations with an "effective" corporate compliance program may receive reduced penalties. The seven components of an effective program as defined in the guidelines are: (1) Standards and procedures; (2) oversight responsibilities; (3) employee training; (4) monitoring and auditing; (5) reporting systems; (6) enforcement and discipline; and (7) response and prevention. Lack of a compliance program needlessly exposes the organization to an avoidable risk of damage from non-compliance--whether intentional or not. Moreover, an effective program can contribute to the efficient operation of the organization and be a key piece of its corporate culture.

The Xyrem risk management program.

PubMed

Fuller, David E; Hornfeldt, Carl S; Kelloway, Judy S; Stahl, Pamela J; Anderson, Todd F

2004-01-01

Sodium oxybate, also known as gamma-hydroxybutyric acid (GHB), was discovered in 1960 and has been described both as a therapeutic agent with high medical value and, more recently, a substance of abuse. The naturally occurring form of this drug is found in various body tissues but has been studied most extensively in the CNS where its possible function as a neurotransmitter continues to be studied. Sodium oxybate has been approved in different countries for such varied uses as general anaesthesia, the treatment of alcohol withdrawal and addiction, and, most recently, cataplexy associated with narcolepsy. During the 1980s, easy access to GHB-containing products led to various unapproved uses, including weight loss, bodybuilding and the treatment of sleeplessness, sometimes with serious long-term effects. The availability of these unapproved and unregulated forms of the drug led to GHB and its analogues being popularised as substances of abuse and subsequent notoriety as agents used in drug-facilitated sexual assault, or 'date rape', eventually leading to the prohibition of GHB sales in the US. Legal efforts to control the sale and distribution of GHB and its analogues nearly prevented the clinical development of sodium oxybate for narcolepsy in the US. However, following extensive discussions with a variety of interested parties, a satisfactory solution was devised, including legislative action and the development of the Xyrem Risk Management Program. Amendments to the US Controlled Substances Act made GHB a schedule I drug, but also contained provisions that allow US FDA-approved products to be placed under schedule III. This unique, bifurcated schedule for sodium oxybate/GHB allowed the clinical development of sodium oxybate to proceed and, in July 2002, it was approved by the FDA as an orphan drug for the treatment of cataplexy in patients with narcolepsy as Xyrem(sodium oxybate) oral solution. To promote the safe use of sodium oxybate, as well as alleviate concerns over possible diversion and abuse following product approval, a proprietary restricted drug distribution system was created, called the Xyrem Success Program. Components of the programme include a centralised distribution and dispensing system, a physician and patient registry, compulsory educational materials for patients and physicians, a specially trained pharmacy staff, a method for tracking prescription shipments, and an initial post-marketing surveillance programme. The system has created a unique opportunity to provide both physician and patient education and ongoing patient counselling, promoting greater drug safety and enhanced patient compliance.

77 FR 13343 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-06

...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Termination of... acceptance of nominations for the Early Feasibility Study Investigational Device Exemption (IDE) Applications... technologies to participate in a pilot program for early feasibility study IDE applications. FDA is also...

Waiver Culture: The Unintended Consequence of Ethics Compliance

ERIC Educational Resources Information Center

Genova, Gina L.

2008-01-01

The passage of the U.S. Sarbanes-Oxley Act (2002) spawned a series of compliance and ethics programs --the revised Principles of Federal Prosecution of Business Organizations known as the Thompson Memo (Thompson, 2003), the revised Federal Sentencing Guidelines that included the Effective Compliance and Ethics Program and the corporate…

Task force on compliance and enforcement. Final report. Volume 2

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1978-03-01

Recommendations for measures to strengthen the FEA enforcement program in the area of petroleum price regulation are presented. Results of task force efforts are presented in report and recommendations sections concerned with pending cases, compliance program organization, enforcement powers, compliance strategy, and audit staffing and techniques. (JRD)

78 FR 62488 - Energy Conservation Program: Compliance Date for the Dehumidifier Test Procedure

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-22

... Conservation Program: Compliance Date for the Dehumidifier Test Procedure AGENCY: Office of Energy Efficiency.... Department of Energy (DOE) proposes to revise the compliance date for the dehumidifier test procedures... manufacturers to test using only the active mode provisions in the test procedure for dehumidifiers currently...

76 FR 5415 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-31

... Rule Change Regarding Rule 4.20--Anti-Money Laundering Compliance Program January 25, 2011. I... Rule 4.20, Anti-Money Laundering Compliance Program, to require all Trading Permit Holders or TPH... or TPH organization's existence to ensure anti-money laundering compliance is in place and...

40 CFR 72.90 - Annual compliance certification report.

Code of Federal Regulations, 2014 CFR

2014-07-01

... is subject to the Acid Rain emissions limitations, the designated representative of the source at... the source and the affected units at the source in compliance with the Acid Rain Program, whether each... covered by the report in compliance with the requirements of the Acid Rain Program applicable to the unit...

40 CFR 72.90 - Annual compliance certification report.

Code of Federal Regulations, 2011 CFR

2011-07-01

... is subject to the Acid Rain emissions limitations, the designated representative of the source at... the source and the affected units at the source in compliance with the Acid Rain Program, whether each... covered by the report in compliance with the requirements of the Acid Rain Program applicable to the unit...

40 CFR 72.90 - Annual compliance certification report.

Code of Federal Regulations, 2012 CFR

2012-07-01

... is subject to the Acid Rain emissions limitations, the designated representative of the source at... the source and the affected units at the source in compliance with the Acid Rain Program, whether each... covered by the report in compliance with the requirements of the Acid Rain Program applicable to the unit...

40 CFR 72.90 - Annual compliance certification report.

Code of Federal Regulations, 2013 CFR

2013-07-01

... is subject to the Acid Rain emissions limitations, the designated representative of the source at... the source and the affected units at the source in compliance with the Acid Rain Program, whether each... covered by the report in compliance with the requirements of the Acid Rain Program applicable to the unit...

78 FR 35631 - Proposed Information Collection Request; Comment Request; 40 CFR Part 64 Compliance Assurance...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-13

... the fact that most facilities are now using electronic monitoring to conduct their recording, thus... Request; Comment Request; 40 CFR Part 64 Compliance Assurance Monitoring Program AGENCY: Environmental... an information collection request, ``40 CFR Part 64 Compliance Assurance Monitoring Program'' (EPA...

40 CFR 52.744 - Small business stationary source technical and environmental compliance assistance program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Small business stationary source technical and environmental compliance assistance program. 52.744 Section 52.744 Protection of Environment... PLANS Illinois> § 52.744 Small business stationary source technical and environmental compliance...

40 CFR 52.798 - Small business stationary source technical and environmental compliance assistance program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Small business stationary source technical and environmental compliance assistance program. 52.798 Section 52.798 Protection of Environment... PLANS Indiana § 52.798 Small business stationary source technical and environmental compliance...

Compliance and Practices in Transition Planning: A Review of Individualized Education Program Documents

ERIC Educational Resources Information Center

Landmark, Leena Jo; Zhang, Dalun

2013-01-01

This study examined the extent to which transition components of students’ Individualized Education Programs (IEPs) were compliant with IDEIA 2004; the extent to which transition components provided evidence of best practices; the association among disability, ethnicity, compliance, and practices; and the relationship between compliance and best…

Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).

PubMed

Hoffman, Keith B; Demakas, Andrea R; Dimbil, Mo; Tatonetti, Nicholas P; Erdman, Colin B

2014-11-01

The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. To determine the extent of "stimulated reporting" in the modern-day FAERS database. One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.

40 CFR 501.16 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Requirements for compliance evaluation programs. 501.16 Section 501.16 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SEWAGE SLUDGE STATE SLUDGE MANAGEMENT PROGRAM REGULATIONS Development and Submission of State Programs...

76 FR 14896 - Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

...] Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public... specific regulatory guidance related to the Federal Select Agent Program established under the Public.... Sarah Kwiatkowski, Veterinary Program Assistant, APHIS Select Agent Program, APHIS, 4700 River Road Unit...

76 FR 17617 - Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-30

...] Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public... specific regulatory guidance related to the Federal Select Agent Program established under the Public.... Sarah Kwiatkowski, Veterinary Program Assistant, APHIS Select Agent Program, APHIS, 4700 River Road Unit...

FDA 2011 process validation guidance: lifecycle compliance model.

PubMed

Campbell, Cliff

2014-01-01

This article has been written as a contribution to the industry's efforts in migrating from a document-driven to a data-driven compliance mindset. A combination of target product profile, control engineering, and general sum principle techniques is presented as the basis of a simple but scalable lifecycle compliance model in support of modernized process validation. Unit operations and significant variables occupy pole position within the model, documentation requirements being treated as a derivative or consequence of the modeling process. The quality system is repositioned as a subordinate of system quality, this being defined as the integral of related "system qualities". The article represents a structured interpretation of the U.S. Food and Drug Administration's 2011 Guidance for Industry on Process Validation and is based on the author's educational background and his manufacturing/consulting experience in the validation field. The U.S. Food and Drug Administration's Guidance for Industry on Process Validation (2011) provides a wide-ranging and rigorous outline of compliant drug manufacturing requirements relative to its 20(th) century predecessor (1987). Its declared focus is patient safety, and it identifies three inter-related (and obvious) stages of the compliance lifecycle. Firstly, processes must be designed, both from a technical and quality perspective. Secondly, processes must be qualified, providing evidence that the manufacturing facility is fully "roadworthy" and fit for its intended purpose. Thirdly, processes must be verified, meaning that commercial batches must be monitored to ensure that processes remain in a state of control throughout their lifetime.

36 CFR 1154.150 - Program accessibility: Existing facilities.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TRANSPORTATION BARRIERS COMPLIANCE BOARD ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD § 1154.150 Program accessibility: Existing facilities. (a) General. The agency shall operate each program or activity so that the...

Above reproach: developing a comprehensive ethics and compliance program.

PubMed

Yuspeh, A; Whalen, K; Cecelic, J; Clifton, S; Cobb, L; Eddy, M; Fainter, J; Packard, J; Postal, S; Steakley, J; Waddey, P

1999-01-01

How can a healthcare organization improve the public's confidence in the conduct of its business operations? What can it do to ensure that it can thrive despite being the subject of public and governmental scrutiny and doubt? Healthcare providers must establish standards of conduct that are above reproach and ensure that those standards are clearly articulated and strictly adhered to. This article describes the merits of a comprehensive ethics and compliance program, suggests five basic elements of such a program--organizational support/structure, setting standards, creating awareness, establishing a mechanism for reporting exceptions, and monitoring and auditing--and then demonstrates how those elements should be applied in several high-risk areas. Fundamentally, an ethics and compliance program has two purposes: to ensure that all individuals in an organization observe pertinent laws and regulations in their work; and to articulate a broader set of aspirational ethical standards that are well-understood within the organization and become a practical guideline for organization members making decisions that raise ethical concerns. Every ethics and compliance program should contain certain fundamental aspects. First, the effort must have the active support of the most senior management in the organization. To instill a commitment to ethics and compliance absent a clear and outspoken commitment to such purposes by organization leaders is simply impossible. Second, an ethics and compliance program is fundamentally about organizational culture--about instilling a commitment to observe the law and, more generally, to do the right thing. Third, ethics and compliance are responsibilities of operating management (sometimes called line management). Although staff such as compliance officers are obligated to provide the necessary resources for a successful program and to design the program, such staff officers cannot achieve implementation and execution. Only operating managers can do that. Fourth, an ethics and compliance effort should be about the conduct of individuals, not about "checking the boxes" in a model plan or generating attractive written or educational materials. Such an effort is about individuals on a day-to-day basis knowing what is expected of them and doing it and about never compromising integrity, regardless of pressures faced. A great deal of progress has been made in healthcare organizations in the development of increasingly sophisticated ethics and compliance programs. A particularly energetic focus has been placed on these programs since formal government guidance regarding compliance programs was first issued in the laboratory area about two years ago and as more sophisticated automated monitoring tools have been developed. As ethics and compliance programs have become more sophisticated, certain best practices have been established. This discussion will set forth approaches to ethics and compliance in the context of what are believed to be illustrative best practices. Much of what is described here is descriptive of the efforts of Columbia/HCA Healthcare Corporation from October 1997 to the present; however, this article has been presented not as a mere descriptive piece but rather as a set of normative guidelines. We hope that other healthcare providers will find this to be of practical use. Provider settings pose certain unique challenges that are specifically addressed in this discussion; however, many of the issues raised can be adapted to other healthcare organizations. For simplicity's sake, because the authors of this article all work on a daily basis primarily with hospitals, the article is written from a hospital perspective.

Sustained Reduction of Ventilator-Associated Pneumonia Rates Using Real-Time Course Correction With a Ventilator Bundle Compliance Dashboard.

PubMed

Talbot, Thomas R; Carr, Devin; Parmley, C Lee; Martin, Barbara J; Gray, Barbara; Ambrose, Anna; Starmer, Jack

2015-11-01

The effectiveness of practice bundles on reducing ventilator-associated pneumonia (VAP) has been questioned. To implement a comprehensive program that included a real-time bundle compliance dashboard to improve compliance and reduce ventilator-associated complications. DESIGN Before-and-after quasi-experimental study with interrupted time-series analysis. SETTING Academic medical center. In 2007 a comprehensive institutional ventilator bundle program was developed. To assess bundle compliance and stimulate instant course correction of noncompliant parameters, a real-time computerized dashboard was developed. Program impact in 6 adult intensive care units (ICUs) was assessed. Bundle compliance was noted as an overall cumulative bundle adherence assessment, reflecting the percentage of time all elements were concurrently in compliance for all patients. The VAP rate in all ICUs combined decreased from 19.5 to 9.2 VAPs per 1,000 ventilator-days following program implementation (P<.001). Bundle compliance significantly increased (Z100 score of 23% in August 2007 to 83% in June 2011 [P<.001]). The implementation resulted in a significant monthly decrease in the overall ICU VAP rate of 3.28/1,000 ventilator-days (95% CI, 2.64-3.92/1,000 ventilator-days). Following the intervention, the VAP rate decreased significantly at a rate of 0.20/1,000 ventilator-days per month (95% CI, 0.14-0.30/1,000 ventilator-days per month). Among all adult ICUs combined, improved bundle compliance was moderately correlated with monthly VAP rate reductions (Pearson correlation coefficient, -0.32). A prevention program using a real-time bundle adherence dashboard was associated with significant sustained decreases in VAP rates and an increase in bundle compliance among adult ICU patients.

32 CFR 644.318 - Compliance with State Coastal Zone Management Programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Compliance with State Coastal Zone Management... (CONTINUED) REAL PROPERTY REAL ESTATE HANDBOOK Disposal § 644.318 Compliance with State Coastal Zone Management Programs. Subpart H will outline the provisions of the Coastal Zone Management Act of 1972, as...

32 CFR 644.318 - Compliance with State Coastal Zone Management Programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 4 2011-07-01 2011-07-01 false Compliance with State Coastal Zone Management... (CONTINUED) REAL PROPERTY REAL ESTATE HANDBOOK Disposal § 644.318 Compliance with State Coastal Zone Management Programs. Subpart H will outline the provisions of the Coastal Zone Management Act of 1972, as...

45 CFR 800.102 - Compliance with Federal law.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 3 2013-10-01 2013-10-01 false Compliance with Federal law. 800.102 Section 800... MULTI-STATE PLAN PROGRAM Multi-State Plan Program Issuer Requirements § 800.102 Compliance with Federal law. (a) Public Health Service Act. As a condition of participation in the MSPP, an MSPP issuer must...

45 CFR 800.102 - Compliance with Federal law.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 3 2014-10-01 2014-10-01 false Compliance with Federal law. 800.102 Section 800... MULTI-STATE PLAN PROGRAM Multi-State Plan Program Issuer Requirements § 800.102 Compliance with Federal law. (a) Public Health Service Act. As a condition of participation in the MSPP, an MSPP issuer must...

Evaluation of an Intervention Program to Increase Immunization Compliance among School Children

ERIC Educational Resources Information Center

Luthy, Karlen E.; Thorpe, Aubrey; Dymock, Leah Clark; Connely, Samantha

2011-01-01

State immunization laws necessitate compliance for students enrolling in a public or private school system. In support of state laws, school nurses expend hours to achieve immunization compliance with school-age children. For the purpose of creating a more efficient system, researchers implemented an educational and incentive program in local…

Ecological Monitoring and Compliance Program 2011 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hansen, D. J.; Anderson, D. C.; Hall, D. B.

The Ecological Monitoring and Compliance (EMAC) Program, funded through the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office, monitors the ecosystem of the Nevada National Security Site and ensures compliance with laws and regulations pertaining to NNSS biota. This report summarizes the program's activities conducted by National Security Technologies, LLC, during calendar year 2011. Program activities included (a) biological surveys at proposed construction sites, (b) desert tortoise compliance, (c) ecosystem monitoring, (d) sensitive plant species monitoring, (e) sensitive and protected/regulated animal monitoring, (f) habitat restoration monitoring, and (g) monitoring of the Nonproliferation Test and Evaluation Complex. Duringmore » 2011, all applicable laws, regulations, and permit requirements were met, enabling EMAC to achieve its intended goals and objectives.« less

Data gaps in toxicity testing of chemicals allowed in food in the United States.

PubMed

Neltner, Thomas G; Alger, Heather M; Leonard, Jack E; Maffini, Maricel V

2013-12-01

In the United States, chemical additives cannot be used in food without an affirmative determination that their use is safe by FDA or additive manufacturer. Feeding toxicology studies designed to estimate the amount of a chemical additive that can be eaten safely provide the most relevant information. We analyze how many chemical additives allowed in human food have feeding toxicology studies in three toxicological information sources including the U.S. Food and Drug Administration's (FDA) database. Less than 38% of FDA-regulated additives have a published feeding study. For chemicals directly added to food, 21.6% have feeding studies necessary to estimate a safe level of exposure and 6.7% have reproductive or developmental toxicity data in FDA's database. A program is needed to fill these significant knowledge gaps by using in vitro and in silico methods complemented with targeted in vivo studies to ensure public health is protected. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

Incentives for orphan drug research and development in the United States.

PubMed

Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Szeinbach, Sheryl L; Visaria, Jay

2008-12-16

The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study period. The FDA listed 1,793 orphan designations and 322 approvals between 1983 and 2007. Cancer was the main group of diseases targeted for orphan approvals. Eighty-three companies concentrated 67.7% of the total orphan NMEs approvals. The average time from orphan designation to FDA approval was 4.0 +/- 3.3 years (mean +/- standard deviation). The average maximum effective patent and market exclusivity life was 11.7 +/- 5.0 years for orphan NME. OD market exclusivity increased the average maximum effective patent and market exclusivity life of ODs by 0.8 years. Public programs, federal regulations, and policies support orphan drugs R&D. Grants, research design support, FDA fee waivers, tax incentives, and orphan drug market exclusivity are the main incentives for orphan drug R&D. Although the 7-year orphan drug market exclusivity provision had a positive yet relatively modest overall effect on effective patent and market exclusivity life, economic incentives and public support mechanisms provide a platform for continued orphan drug development for a highly specialized market.

Affirmative Action Compliance Program for Fiscal Year 1980

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

Eleven chapters are used to delineate Lawrence Berkeley Lab's compliance, namely: (1) a description of LBL's facility, history, staff, mission, etc; (2) Affirmative Action policy statement; (3) dissemination (internal and external) per the implementation regulations; (4) identification of Affirmative Action responsibilities; (5) personnel policies; (6) past goal-setting process and accomplishment; (7) work-force array, job groups, availability determinations, identification of underutilization, and goals and timetables; (8) identification of problem areas and action-oriented programs; (9) listing and brief description of specific LBL Affirmative Action programs; (10) compliance with sex-discrimination guidelines; and (11) compliance with guidelines on discrimination because of religion or nationalmore » origin.« less

75 FR 23223 - Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-03

...] Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public... Select Agent Program established under the Public Health Security and Bioterrorism Preparedness and... Roberson, Veterinary Permit Examiner, APHIS Select Agent Program, VS, ASAP, APHIS, 4700 River Road Unit 2...

40 CFR 160.12 - Statement of compliance or non-compliance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Statement of compliance or non-compliance. 160.12 Section 160.12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS General Provisions § 160.12 Statement of compliance or...

National standards for the long-term care ombudsman program and a tool to assess compliance: the Huber Badrak Borders Scales.

PubMed

Huber, R; Borders, K W; Badrak, K; Netting, F E; Nelson, H W

2001-04-01

We propose national standards previously recommended for the Long-Term Care Ombudsman Program by an Institute of Medicine program evaluation committee, and introduce a tool to measure the compliance of local ombudsman programs to those standards: the Huber Badrak Borders Scales. The best practices for ombudsman programs detailed in the committee's report were adapted to 43 Likert-type scales that were then averaged into 10 infrastructure component scales: (a) program structure, (b) qualifications of local ombudsmen, (c) legal authority, (d) financial resources, (e) management information systems, (f) legal resources, (g) human resources, (h) resident advocacy services, (i) systemic advocacy, and (j) educational services. The scales were pilot-tested in 1996 and 1999 with Kentucky ombudsmen. The means of 9 of these 10 scales were higher in 1999 than in 1996, suggesting that local ombudsman programs were more in compliance with the proposed standards in 1999 than three years earlier. The development process consisted of 10 adopt-test-revise-retest steps that can be replicated by other types of programs to develop program compliance tools.

Surveillance of Salmonella enteritidis in layer houses: a retrospective comparison of the Food and Drug Administration's egg safety rule (2010-2011) and the California Egg Quality Assurance Program (2007-2011).

PubMed

Pitesky, Maurice; Charlton, Bruce; Bland, Mark; Rolfe, Dan

2013-03-01

Between July 2007 and December 2011, 2660 environmental drag swab samples were collected in total from California layer flocks on behalf of the California Egg Quality Assurance Program (CEQAP), the egg safety rule (21 CFR Parts 16 and 118) of the Food and Drug Administration (FDA), or both. The samples were processed by the California Animal Health and Food Safety Lab, and positive or negative results for Salmonella enterica serovar Enteritidis (SE) were recorded. This study retrospectively compares the differences between the FDA and CEQAP programs with respect to their SE environmental sampling surveillance results. To accomplish this comparison, two different CEQAP (new and old) data sets representing different SE environmental surveillance approaches in the life of the flock were compared against each other and against the FDA's SE environmental testing plan. Significant differences were noted between the CEQAP and FDA programs with respect to the prevalence of SE in the farm environment. Analyses of the prevalence of SE at different stages in the flock's life cycle (chick papers, preproduction, midproduction, postmolt, and premarket) found the highest prevalence of SE in premarket (11.9%), followed by postmolt (3.5%) and midproduction (3.4%), and there was a tie between chick papers and preproduction (2.1%). To assess the main effects of the presence of SE in the farm environment, backwards binary logistic regression was used. Of six independent variables examined (age of flock, year, season, owner, CEQAP membership, and analysis of pooled samples vs. individual swabs), only age of flock, owner, and year were determined to be significant factors in the final model. Although CEQAP membership and pooling vs. individuals swabs were not included in the final model, Pearson chi-square tests did show significantly higher odds of SE for non-CEQAP member farms and higher odds of SE in pooled samples vs. individual swabs.

Ecological Monitoring and Compliance Program 2007 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hansen, Dennis; Anderson, David; Derek, Hall

2008-03-01

In accordance with U.S. Department of Energy (DOE) Order 450.1, 'Environmental Protection Program', the Office of the Assistant Manager for Environmental Management of the DOE, National Nuclear Security Administration Nevada Site Office (NNSA/NSO) requires ecological monitoring and biological compliance support for activities and programs conducted at the Nevada Test Site (NTS). National Security Technologies, LLC (NSTec), Ecological Services has implemented the Ecological Monitoring and Compliance (EMAC) Program to provide this support. EMAC is designed to ensure compliance with applicable laws and regulations, delineate and define NTS ecosystems, and provide ecological information that can be used to predict and evaluate themore » potential impacts of proposed projects and programs on those ecosystems. This report summarizes the EMAC activities conducted by NSTec during calendar year 2007. Monitoring tasks during 2007 included eight program areas: (a) biological surveys, (b) desert tortoise compliance, (c) ecosystem mapping and data management, (d) sensitive plant monitoring, (e) sensitive and protected/regulated animal monitoring, (f) habitat monitoring, (g) habitat restoration monitoring, and (h) biological monitoring at the Nonproliferation Test and Evaluation Complex (NPTEC). The following sections of this report describe work performed under these eight areas.« less

FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

Cancer.gov

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.

[Impulsivity: What are the consequences on compliance to rehabilitation?].

PubMed

Cancel, A; Naudet, F; Rousseau, P F; Millet, B; Drapier, D

2016-08-01

Impulsivity is a transnosographical dimension with major consequences on medical care with which psychiatrists are frequently confronted. Furthermore, compliance is a major variable that can affect the efficiency of therapeutics and hospitalizations in psychiatry. A study was carried out in three drug and alcohol rehabilitation hospitalization units to find out if impulsivity can have consequences on compliance. The studied population was composed of 85 patients aged from 18 to 70, hospitalized for one or more addiction disorders in a psychometric hospital in Vannes (France). Impulsivity was measured for all patients with the BIS-11 at the beginning of the rehabilitation program. Because no tool to evaluate a total rehab program compliance existed, a scale, used at the end of the hospitalization, was created to measure patient compliance. This score was composed of two simple numeric scales (one used by the nurses and one used by the patient's psychiatrist) and a coefficient of hospitalization duration that was the ratio of completed to planned days of hospitalization. Correlations were made between the different dimensions: impulsivity and compliance, impulsivity and hospitalization conditions, compliance and hospitalization conditions (voluntary or involuntary, planned by a psychiatrist or not, etc.). The main statistically significant result of the study was a negative correlation existing between the motor dimension of impulsivity and compliance (r=-0.37 and P=0.001). The other dimensions of impulsivity showed no significant correlation with compliance score. The study revealed that the different hospitalization conditions showed no link with compliance or impulsivity. These original results show that motor impulsive patients need an adaptation of the rehabilitation programs. Shorter programs might be more efficient. Copyright © 2015 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

77 FR 40072 - Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0603] Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New... statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for...

75 FR 68702 - Regulation SHO

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-09

... extended compliance period will give industry participants additional time for programming and testing for... time for programming and testing for compliance with the Rule's requirements. We have been informed that there have been some delays in the programming process, due in part to certain information, which...

United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise.

PubMed

Khan, Saeed R; Kona, Ravikanth; Faustino, Patrick J; Gupta, Abhay; Taylor, Jeb S; Porter, Donna A; Khan, Mansoor

2014-05-01

The Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry. During the early stages of development, special attention was paid to program operation, labeling requirements, and the cost benefits associated with this program. In addition to the substantial cost benefits, the program also provides the FDA's Center for Drug Evaluation and Research with significant scientific understanding and pharmaceutical resource. As a result of this unique resource, numerous regulatory research opportunities to improve public health present themselves from this distinctive scientific database, which includes examples of products shelf life, their long-term stability issues, and various physical and chemical tests to identify such failures. The database also serves as a scientific resource for mechanistic understanding and identification of test failures leading to the development of new formulations or more robust packaging. It has been recognized that SLEP is very important in maintaining both national security and public welfare by confirming that the stockpiled pharmaceutical products meet quality standards after the "expiration date" assigned by the sponsor. SLEP research is an example of regulatory science that is needed to best ensure product performance past the original shelf life. The objective of this article is to provide a brief history and background and most importantly the public health benefits of the SLEP. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

7 CFR 773.9 - Environmental compliance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AGRICULTURE SPECIAL PROGRAMS SPECIAL APPLE LOAN PROGRAM § 773.9 Environmental compliance. (a) Except as... cooperative which deals with the production, processing or marketing of apples; and (6) Payment of loan...

7 CFR 773.9 - Environmental compliance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AGRICULTURE SPECIAL PROGRAMS SPECIAL APPLE LOAN PROGRAM § 773.9 Environmental compliance. (a) Except as... cooperative which deals with the production, processing or marketing of apples; and (6) Payment of loan...

7 CFR 520.4 - Responsibilities.

Code of Federal Regulations, 2010 CFR

2010-01-01

... compliance with the provisions of NEPA and related laws, policies, plans, programs, and projects. The ARS... Administrator for assuring that ARS programs are in compliance with the policies and procedures of NEPA. ...

7 CFR 520.4 - Responsibilities.

Code of Federal Regulations, 2012 CFR

2012-01-01

... compliance with the provisions of NEPA and related laws, policies, plans, programs, and projects. The ARS... Administrator for assuring that ARS programs are in compliance with the policies and procedures of NEPA. ...

7 CFR 520.4 - Responsibilities.

Code of Federal Regulations, 2011 CFR

2011-01-01

... compliance with the provisions of NEPA and related laws, policies, plans, programs, and projects. The ARS... Administrator for assuring that ARS programs are in compliance with the policies and procedures of NEPA. ...

12 CFR 1710.19 - Compliance and risk management programs; compliance with other laws.

Code of Federal Regulations, 2011 CFR

2011-01-01

... management program. (1) An Enterprise shall establish and maintain a risk management program that is reasonably designed to manage the risks of the operations of the Enterprise. (2) The risk management program... executive officer of the Enterprise. The risk management officer shall report regularly to the board of...

Developing an in vitro understanding of patient experience with hydrofluoroalkane-metered dose inhalers.

PubMed

Doub, William H; Shah, Vibhakar; Limb, Susan; Guo, Changning; Liu, Xiaofei; Ngo, Diem

2014-11-01

As a result of the Montreal Protocol on Substances that Deplete the Ozone Layer, manufacturers of metered dose inhalers began reformulating their products to use hydrofluoroalkanes (HFAs) as propellants in place of chlorofluorocarbons (CFCs). Although the new products are considered safe and efficacious by the US Food and Drug Administration (FDA), a large number of complaints have been registered via the FDA's Adverse Events Reporting System (FAERS)-more than 7000 as of May 2013. To develop a better understanding of the measurable parameters that may, in part, determine in vitro performance and thus patient compliance, we compared several CFC- and HFA-based products with respect to their aerodynamic performance in response to changes in actuator cleaning interval and interactuation delay interval. Comparison metrics examined in this study were: total drug delivered ex-actuator, fine particle dose (<5 μm), mass median aerodynamic diameter, plume width, plume temperature, plume impaction force, and actuator orifice diameter. Overall, no single metric or test condition distinguishes HFA products from CFC products, but, for individual products tested, there were a combination of metrics that differentiated one from another. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Generic Pharmaceutical Association (GPhA) - 2015 CMC Workshop (June 9-10, 2015 - Bethesda, Maryland, USA).

PubMed

Komlos, D

2015-07-01

Nearly 400 professionals attended the 2-day Generic Pharmaceutical Association (GPhA) workshop dedicated to fostering discussions on the FDA's chemistry, manufacturing and controls (CMC) expectations for abbreviated new drug applications (ANDAs), enhanced regulatory filing requirements, and other topics, as CMC takes root in the Office of Pharmaceutical Quality (OPQ). Following the keynote address by Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research (CDER) and Acting Director of OPQ, and an update from the Office of Generic Drugs (OGD) by Ted Sherwood, Acting Director of the OGD's Office of Regulatory Operations, plenary sessions took place covering OPQ updates, management plans, Generic Drug User Fee Amendments of 2012 (GDUFA) backlog, year 1 and 2 cohorts, drug substance, defining starting materials, quality related refuse-to-receive standards, risk and team-based integrated quality assessment, deficiencies and information requests - CMC submissions, emerging technologies, compliance and inspection, lifecycle management of drug products, quality metrics, pharmaceutically relevant dissolution specifications, and communication and project management. This report will provide a summary of conference highlights. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

Ecological Monitoring and Compliance Program 2008 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hansen, Dennis J.; Anderson, David C.; Hall, Derek B.

2009-04-30

The Ecological Monitoring and Compliance Program, funded through the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office (NNSA/NSO), monitors the ecosystem of the Nevada Test Site (NTS) and ensures compliance with laws and regulations pertaining to NTS biota. This report summarizes the program’s activities conducted by National Security Technologies, LLC (NSTec), during calendar year 2008. Program activities included (a) biological surveys at proposed construction sites, (b) desert tortoise compliance, (c) ecosystem mapping and data management, (d) sensitive plant species monitoring, (e) sensitive and protected/regulated animal monitoring, (f) habitat monitoring, (g) habitat restoration monitoring, and (h) monitoring ofmore » the Nonproliferation Test and Evaluation Complex (NPTEC).« less

Fraud and abuse. Building an effective corporate compliance program.

PubMed

Matusicky, C F

1998-04-01

In 1997, General Health System (GHS), a not-for-profit integrated delivery system headquartered in Baton Rouge, Louisiana, developed a formal corporate compliance program. A newly appointed corporate compliance officer worked with key GHS managers and employees to assess the organization's current fraud and abuse prevention practices and recommend changes to meet new regulatory and organizational requirements. Then a structure for implementing these changes was developed, with staff training at its core. The program required a significant initial outlay of financial and human resources. The benefits to the organization, however, including a greater ability to respond quickly and effectively to possible compliance problems and better organizational communications, were worth the investment.

40 CFR 52.1110 - Small business stationary source technical and environmental compliance assistance program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... technical and environmental compliance assistance program. 52.1110 Section 52.1110 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1110 Small business stationary source technical and environmental...

75 FR 38833 - Walker River Basin Acquisition Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-06

... Acquisition Program recipient and has therefore determined National Environmental Policy Act (NEPA) compliance... that NEPA compliance is not required in the July 2009 Draft EIS and shared the decision at the August... address the lake's environmental conditions. Reclamation's role related to the Acquisition Program as...

Getting Your Ducks in a Row: IT Governance, Risk, and Compliance Programs in Higher Education

ERIC Educational Resources Information Center

Bichsel, Jacqueline; Feehan, Patrick

2014-01-01

Higher education IT governance, risk, and compliance (GRC) programs are in the development stage. Few institutions have all three programs in place, and many institutions are unclear where they should start when instituting or maturing their IT GRC programs. In addition, they are often uncertain as to whether GRC programs should be developed in…

[Effects of TES program on exercise capacity, self-efficacy and patient compliance in patients with myocardial infarction].

PubMed

Choo, Jina; Kim, Ja-Mae; Hong, Kyung-Pyo

2003-12-01

This study aimed to develop a TES program to improve exercise capacity to promote patient compliance to the prescribed exercise, and to test the feasibility of the program. The 8-week TES program consisted of three components : exercise training, self-efficacy enhancement and social support. Using the matching of gender, age, and the left ventricular ejection fraction, thirty one subjects were consecutively assigned to either TES group (n=15, 52+7 years) or Control group (n=16, 58+11 years) 3 weeks after MI. With the exception of exercise compliance (only after the TES program), the exercise capacity and exercise self-efficacy were both measured both before and after the 8-week TES program. The VO2peak (p=.043), anaerobic threshold (p=.023) and exercise duration (p=.015) improved in TES group compared to Control group after 8 weeks. The cardiac exercise self-efficacy (p=.036) was significantly higher in TES group than Control group. There was a significant increase of exercise compliance(p=.005) in TES group compared to Control group. The 8-week TES program improved the exercise capacity, exercise self-efficacy and exercise compliance. A appropriately implemented TES program in cardiovascular nursing practice may promote healthy behavioral modification and, therefore, contributing to reduce the risk of mortality and morbidity in MI patients.

7 CFR 520.4 - Responsibilities.

Code of Federal Regulations, 2014 CFR

2014-01-01

... compliance with the provisions of NEPA and related laws, policies, plans, programs, and projects. The ARS... Administrator for assuring that ARS programs are in compliance with the policies and procedures of NEPA. [51 FR...

7 CFR 520.4 - Responsibilities.

Code of Federal Regulations, 2013 CFR

2013-01-01

... compliance with the provisions of NEPA and related laws, policies, plans, programs, and projects. The ARS... Administrator for assuring that ARS programs are in compliance with the policies and procedures of NEPA. [51 FR...

40 CFR 52.2586 - Small business stationary source technical and environmental compliance assistance program.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PLANS (CONTINUED) Wisconsin § 52.2586 Small business stationary source technical and environmental compliance assistance program. The Wisconsin small business stationary source technical and environmental...

40 CFR 52.2586 - Small business stationary source technical and environmental compliance assistance program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PLANS (CONTINUED) Wisconsin § 52.2586 Small business stationary source technical and environmental compliance assistance program. The Wisconsin small business stationary source technical and environmental...

40 CFR 52.2586 - Small business stationary source technical and environmental compliance assistance program.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PLANS (CONTINUED) Wisconsin § 52.2586 Small business stationary source technical and environmental compliance assistance program. The Wisconsin small business stationary source technical and environmental...

40 CFR 52.2586 - Small business stationary source technical and environmental compliance assistance program.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PLANS (CONTINUED) Wisconsin § 52.2586 Small business stationary source technical and environmental compliance assistance program. The Wisconsin small business stationary source technical and environmental...

40 CFR 52.2586 - Small business stationary source technical and environmental compliance assistance program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PLANS (CONTINUED) Wisconsin § 52.2586 Small business stationary source technical and environmental compliance assistance program. The Wisconsin small business stationary source technical and environmental...

Introduction to HACCP.

USDA-ARS?s Scientific Manuscript database

The Hazard Analysis and Critical Control Point (HACCP) food safety inspection program is utilized by both USDA Food Safety Inspection Service (FSIS) and FDA for many of the products they regulate. This science-based program was implemented by the USDA FSIS to enhance the food safety of meat and pou...

Best practices in specialty pharmacy management.

PubMed

Patterson, Courtney J

2013-01-01

Specialty pharmacy is a growing area of research, utilization, and cost. Because of the unique nature of the diseases treated by specialty pharmaceuticals, such as cancer and rheumatoid arthritis, novel management approaches are needed. Advocate Physician Partners (APP) is an entity within the Advocate Health Care Health System in the Chicago and the central Illinois area. It coordinates the care management and managed care contracting between the Advocate Health Care System and more than 4,000 physicians on the medical staffs of Advocate hospitals. APP has experienced a per-member-per-month (PMPM) increase of less than  3% in oncology intravenous medications spend in 2012. This spend refers to the intravenous medications covered under the medical benefits for APP's health maintenance organization (HMO) population. The spend has consistently been less than national projections, and we believe this is tied to the adoption of several key best practices. Prior to instituting the best practices, the yearly percentage increases for oncology spending were 5.52% (2007 to 2008), 9.39% (2008 to 2009), and 5.29% (2009 to 2010). After instituting best practices during the first quarter of 2011, the increases in PMPM were 3.11% (2010 to 2011) and 2.11% (2011 to 2012), which were below previous years. To describe the best practices of specialty pharmacy management adopted by APP, specifically (a) establishing a content expert and governing bodies, (b) ensuring compliance with policies, and (c) providing educational resources. APP has several key result areas (KRAs). One KRA was compliance with appropriate utilization of intravenous oncology protocols for its HMO population. The protocols for each medication outline the appropriate indication and patient population. These protocols were developed and reviewed by the APP Pharmacy and Technology (PT) committee. The PT-approved indications reflect FDA indications and indications found in national guidelines. The APP KRA target for the utilization of protocols was 80%. The compliance for completing the protocols that correspond to these medications was calculated by tabulating the number of paid claims over the number of completed protocols, resulting in a compliance percentage. APP defined noncompliance as any utilization not outlined in the protocol. Another KRA was physician feedback. APP requires that physicians complete a certain number of continuing medical education (CME) programs provided by APP each year. Feedback from physicians, provided at the end of the CME, were tabulated and utilized for further programs. Additionally, APP strived to increase physician engagement by placing them in key roles that oversaw clinical and business aspects of the organization. In order to meet the KRAs, investigate inappropriate utilization, and become better involved in engaging oncology specialists, APP invested in an oncology clinical pharmacist position. The primary responsibility of the oncology clinical pharmacist was to be a specialty drug resource for the organization with a focus on provider education. The oncology clinical pharmacist was deemed the content expert who developed clinical protocols, educated providers, and encouraged compliance with organizational policies and procedures as it pertained to the KRAs. Since establishing the oncology clinical pharmacist position, APP has seen an increase in protocol compliance. Prior to the institution of this position, the protocol compliance was 62%. In less than 1 year after hiring the oncology clinical pharmacist, the compliance percentage spiked to over 80%. APP has several committees and boards that oversee the clinical and business aspects of the organization. By placing physicians in chairmanship positions of the committees, APP has seen the benefit of handling difficult patient decisions and increased compliance with policies. Lastly, extensive provider education has led to an improved physician satisfaction in the educational initiatives of APP. Greater than 80% of the physicians felt the CME content was relevant to their practices; the content would likely have a positive impact on their practices; and the clinical content was evidence based and accepted by the medical community. By hiring an oncology clinical pharmacist, engaging physicians by placing them in key roles, and providing more specialist-specific education, APP has improved its KRAs and compliance percentages. APP achieved success in containing expenditures for oncology intravenous medications by implementing key best practices combined with traditional management strategies.

Have antiepileptic drug prescription claims changed following the FDA suicidality warning? An evaluation in a state Medicaid program.

PubMed

Mittal, Manish; Harrison, Donald L; Miller, Michael J; Farmer, Kevin C; Thompson, David M; Ng, Yu-Tze

2014-05-01

In January 2008, the Food and Drug Administration (FDA) communicated concerns and, in May 2009, issued a warning about an increased risk of suicidality for all antiepileptic drugs (AEDs). This research evaluated the association between the FDA suicidality communications and the AED prescription claims among members with epilepsy and/or psychiatric disorder. A longitudinal interrupted time-series design was utilized to evaluate Oklahoma Medicaid claims data from January 2006 through December 2009. The study included 9289 continuously eligible members with prevalent diagnoses of epilepsy and/or psychiatric disorder and at least one AED prescription claim. Trends, expressed as monthly changes in the log odds of AED prescription claims, were compared across three time periods: before (January 2006 to January 2008), during (February 2008 to May 2009), and after (June 2009 to December 2009) the FDA warning. Before the FDA warning period, a significant upward trend of AED prescription claims of 0.01% per month (99% CI: 0.008% to 0.013%, p<0.0001) was estimated. In comparison to the prewarning period, no significant change in trend was detected during (-20.0%, 99% CI: -70.0% to 30.0%, p=0.34) or after (80.0%, 99% CI: -20.0% to 200.0%, p=0.03) the FDA warning period. After stratification, no diagnostic group (i.e., epilepsy alone, epilepsy and comorbid psychiatric disorder, and psychiatric disorder alone) experienced a significant change in trend during the entire study period (p>0.01). During the time period considered, the FDA AED-related suicidality warning does not appear to have significantly affected prescription claims of AED medications for the study population. Copyright © 2014 Elsevier Inc. All rights reserved.

Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007.

PubMed

Momper, Jeremiah D; Mulugeta, Yeruk; Green, Dionna J; Karesh, Alyson; Krudys, Kevin M; Sachs, Hari C; Yao, Lynn P; Burckart, Gilbert J

2013-10-01

During pediatric drug development, dedicated pharmacokinetic studies are generally performed in all relevant age groups to support dose selection for subsequent efficacy trials. To our knowledge, no previous assessments regarding the need for an intensive pharmacokinetic study in adolescents have been performed. To compare U.S. Food and Drug Administration (FDA)-approved adult and adolescent drug dosing and to assess the utility of allometric scaling for the prediction of drug clearance in the adolescent population. Adult and adolescent dosing and drug clearance data were obtained from FDA-approved drug labels and publicly available databases containing reviews of pediatric trials submitted to the FDA. Dosing information was compared for products with concordant indications for adolescent and adult patients. Adolescent drug clearance was predicted from adult pharmacokinetic data by using allometric scaling and compared with observed values. Adolescent and adult dosing information and drug clearance. There were 126 unique products with pediatric studies submitted to the FDA since the FDA Amendments Act of 2007, of which 92 had at least 1 adolescent indication concordant with an adult indication. Of these 92 products, 87 (94.5%) have equivalent dosing for adults and adolescent patients. For 18 of these 92 products, a minimum weight or body surface area threshold is recommended for adolescents to receive adult dosing. Allometric scaling predicted adolescent drug clearance with an overall mean absolute percentage error of 17.0%. Approved adult and adolescent drug dosing is equivalent for 94.5% of products with an adolescent indication studied since the FDA Amendments Act of 2007. Allometric scaling may be a useful tool to avoid unnecessary dedicated pharmacokinetic studies in the adolescent population during pediatric drug development, although each development program in adolescents requires a full discussion of drug dosing with the FDA.

FDA's Approach to Regulating Biosimilars.

PubMed

Lemery, Steven J; Ricci, M Stacey; Keegan, Patricia; McKee, Amy E; Pazdur, Richard

2017-04-15

The Biologics Price Competition and Innovation (BPCI) Act, enacted as part of the Affordable Care Act, created a new licensure pathway for biological products demonstrated to be biosimilar with or interchangeable with an FDA-licensed biological product (the "reference product"). The FDA's approach to the regulation of biosimilars is based on the requirements set forth in the BPCI Act. A biosimilar product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between products in terms of safety, purity, and potency. The foundation of a biosimilar development program is an analytic similarity assessment that directly compares the structural/physiochemical and functional properties of the proposed biosimilar with the reference product. Data from clinical studies, which include an assessment of immunogenicity and pharmacokinetics/pharmacodynamics, are used to assess for clinically meaningful differences and not to independently establish the safety and effectiveness of the biosimilar. Like all products that the FDA regulates, the FDA requires that biosimilar products meet the agency's rigorous standards of safety and efficacy for approval. That means patients and health care professionals are able to rely upon the safety and effectiveness of biosimilar products in the same manner as for the reference product. Clin Cancer Res; 23(8); 1882-5. ©2016 AACR . ©2016 American Association for Cancer Research.

Risk evaluation and mitigation strategies: a focus on the mycophenolic acid preparations.

PubMed

Rostas, Sara; Kim, Miae; Gabardi, Steven

2014-03-01

To review risks associated with mycophenolic acid (MPA) preparations and evaluate their required risk evaluation and mitigation strategies (REMS) elements. Articles were identified through a non-date-limited MEDLINE and EMBASE search using the terms fetal toxicity, teratogenicity, risk evaluation and mitigation strategies, REMS, MPA, mycophenolate mofetil, entericcoated MPA, and organ transplant. Information from the Food and Drug Administration (FDA) and the manufacturers of the MPA preparations was also evaluated. The MPA preparations are associated with several potential risks, including gastrointestinal disturbances and myelosuppression; however, their impact on the fetus in pregnant patients taking 1 of these agents poses the greatest risk. The FDA approved REMS programs for all MPA products, both innovator and generic preparations, in September 2012. With evidence of increased risk of miscarriage and birth defects associated with MPA use, the FDA instituted a REMS program that contains both a medication guide and elements to assure safe use (ETASU). The medication guides for the MPA products, which were previously FDA approved, should continue to be distributed to patients who get either an initial prescription filled or a refill. The ETASU requires prescribers to complete training and obtain patient signatures on the Patient-Prescriber Acknowledgment Form. A single, national, voluntary pregnancy registry specific to this medication has been established, and pregnant patients should be encouraged to participate. Although the impact of the MPA REMS on clinical practice is not clear, it is a step toward increasing the understanding of fetal risks with MPA.

Evaluation of patient compliance, quality of life impact and cost-effectiveness of a "test in-train out" exercise-based rehabilitation program for patients with intermittent claudication.

PubMed

Malagoni, Anna Maria; Vagnoni, Emidia; Felisatti, Michele; Mandini, Simona; Heidari, Mahdi; Mascoli, Francesco; Basaglia, Nino; Manfredini, Roberto; Zamboni, Paolo; Manfredini, Fabio

2011-01-01

Patients with intermittent claudication (IC) could benefit from low-cost, effective rehabilitative programs. This retrospective study evaluates compliance, impact on Quality of Life (QoL) and cost-effectiveness of a hospital prescribed, at-home performed (Test-in/Train-out) rehabilitative program for patients with IC. Two-hundred and eighty-nine patients with IC (71 ± 10.1 years, M = 210) were enrolled for a 2-year period. Two daily 10-min home walking sessions at maximal asymptomatic speed were prescribed, with serial check-ups at the hospital. Compliance with the program was assessed by assigning a score of 1 (lowest compliance) to 4 (highest compliance). The SF-36 questionnaire and a constant-load treadmill test were used to evaluate QoL and Initial/Absolute Claudication Distance, respectively. Both direct and indirect costs of the program were considered for cost-effectiveness analysis. Two-hundred and fifty patients (70.5 ± 9.2 years, M = 191), at Fontaine's II-B stage (86%), were included in the study. No adverse events were reported. The average compliance score was 3.1. At discharge, both SF-36 domains and walking performance significantly increased (P < 0.0001). A total of 1,839 in-hospital check-ups (7.36 /patient) were performed. Direct and indirect costs represented 93% and 7% of the total costs, respectively. The average costs of a visit and of a therapy cycle were C68.93 and C507.20, respectively. The cost to walk an additional meter before stopping was C9.22. A Test-in/Train-out program provided favourable patient compliance, QoL impact and cost-effectiveness in patients with IC.

Impact of a pharmaceutical care program on liver transplant patients' compliance with immunosuppressive medication: a prospective, randomized, controlled trial using electronic monitoring.

PubMed

Klein, Anja; Otto, Gerd; Krämer, Irene

2009-03-27

Compliance with immunosuppressive therapy plays a major role in the long-term success of organ transplantation. Thus, strategies to promote compliance in posttransplant care are of particular interest. At the pharmacy department of the University Hospital Mainz, a program for pharmaceutical care of organ transplant patients has been developed for the first time ever. The main objective of the presented study was to examine the influence of this program on liver transplant patients' compliance with immunosuppressive therapy. To measure compliance, medication event monitoring systems were used. Dosing compliance (DC) was calculated for each patient and the mean DC was compared between the two groups. Further direct and indirect methods of measuring compliance served to confirm the electronic compliance data. Pharmaceutical care of liver transplant patients led to a significant increase in compliance with the immunosuppressive therapy. The mean DC of the intervention group was 90%+/-6% compared with 81%+/-12% in the control group (P=0.015). Only two patients (10%) in the intervention group and nine patients (43%) in the control group showed a DC less than 80% (P=0.032). Furthermore, patients in the intervention group were more likely to achieve target blood levels. Patients who received pharmaceutical care with traditional patient care showed significantly better compliance with their immunosuppressive medication than patients who received only traditional patient care. Pharmaceutical care proved to be an effective intervention that should be implemented in posttransplant care.

Using Peer Helpers for Tuberculosis Prevention.

ERIC Educational Resources Information Center

McCue, Maureen; Afifi, Larry Anna

1996-01-01

Describes a peer helper program initiated by the University of Iowa Student Health Services to prevent active tuberculosis development among foreign national students. Before instituting the program, compliance with tuberculosis prevention efforts for those students was less than 5%. Since the peer program was instituted, compliance has risen to…

10 CFR 850.13 - Compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Compliance. 850.13 Section 850.13 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Administrative Requirements § 850.13 Compliance. (a) The responsible employer must conduct activities in compliance with its CBDPP. (b) The responsible...

10 CFR 850.13 - Compliance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Compliance. 850.13 Section 850.13 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Administrative Requirements § 850.13 Compliance. (a) The responsible employer must conduct activities in compliance with its CBDPP. (b) The responsible...

A Review of Factors That Influence Individual Compliance with Mass Drug Administration for Elimination of Lymphatic Filariasis

PubMed Central

Krentel, Alison; Fischer, Peter U.; Weil, Gary J.

2013-01-01

Background The success of programs to eliminate lymphatic filariasis (LF) depends in large part on their ability to achieve and sustain high levels of compliance with mass drug administration (MDA). This paper reports results from a comprehensive review of factors that affect compliance with MDA. Methodology/Principal Findings Papers published between 2000 and 2012 were considered, and 79 publications were included in the final dataset for analysis after two rounds of selection. While results varied in different settings, some common features were associated with successful programs and with compliance by individuals. Training and motivation of drug distributors is critically important, because these people directly interact with target populations, and their actions can affect MDA compliance decisions by families and individuals. Other important programmatic issues include thorough preparation of personnel, supplies, and logistics for implementation and preparation of the population for MDA. Demographic factors (age, sex, income level, and area of residence) are often associated with compliance by individuals, but compliance decisions are also affected by perceptions of the potential benefits of participation versus the risk of adverse events. Trust and information can sometimes offset fear of the unknown. While no single formula can ensure success MDA in all settings, five key ingredients were identified: engender trust, tailor programs to local conditions, take actions to minimize the impact of adverse events, promote the broader benefits of the MDA program, and directly address the issue of systematic non-compliance, which harms communities by prolonging their exposure to LF. Conclusions/Significance This review has identified factors that promote coverage and compliance with MDA for LF elimination across countries. This information may be helpful for explaining results that do not meet expectations and for developing remedies for ailing MDA programs. Our review has also identified gaps in understanding and suggested priority areas for further research. PMID:24278486

76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

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...

40 CFR 147.2921 - Schedule of compliance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS Osage Mineral Reserve... of compliance leading to compliance with the Safe Drinking Water Act and the Osage UIC regulations...

Enforcing the minimum drinking age: state, local and agency characteristics associated with compliance checks and Cops in Shops programs.

PubMed

Montgomery, Jacob M; Foley, Kristie Long; Wolfson, Mark

2006-02-01

To identify state, local and organizational characteristics associated with local law enforcement agencies' implementation of two dramatically different approaches to enforcement of underage drinking laws: compliance checks and Cops in Shops programs. Compliance checks use underage decoys to attempt to purchase alcohol from retail merchants, while Cops in Shops programs deploy undercover law enforcement officers in alcohol outlets to detect and cite persons under the age of 21 who attempt to purchase alcohol. Cross-sectional telephone interview conducted as part of the Tobacco Enforcement Study (TES), which examined enforcement of laws related to youth access to tobacco. Data were collected in 1999 among law enforcement agencies in all 50 states of the United States. Representatives of city police departments, departments of public safety, sheriffs or county police were included (n = 920 local agencies). Alcohol compliance checks and Cops in Shops programs were the primary outcomes. Covariates included state level policies (e.g. beer tax), agency resources (e.g. number of sworn officers) and community demographics (e.g. college dormitory population). Local enforcement agencies were more likely to perform alcohol compliance checks than to have a Cops in Shops program (73.9% compared to 41.1% in cities > 25 000 and 55.7% compared to 23.9% in cities < or = 25 000). Conducting compliance checks for tobacco age-of-sale laws was positively associated with alcohol compliance checks and Cops in Shops (OR 3.30, P < 0.001; OR 1.84, P = 0.001, respectively). Having a Drug Abuse Resistance Education (DARE) officer was negatively related to conducting compliance checks (OR 0.67, P = 0.03). Special community policing units were associated with departments having Cops in Shops programs (OR 1.80, P = 0.006). This study used a nationally representative sample of communities to better understand state and local factors that shape local law enforcement agencies' use of two distinct approaches to underage drinking enforcement. The strong link observed between tobacco and alcohol compliance checks may indicate a culture within some law enforcement agencies supporting strict enforcement of age-of-sale laws.

40 CFR 52.1690 - Small business technical and environmental compliance assistance program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) New York § 52.1690 Small business technical and environmental compliance assistance program. On January 11, 1993, the New York State Department of Environmental Conservation submitted a plan for the... Assistance Program for incorporation in the New York state implementation plan. This plan meets the...

40 CFR 52.2732 - Small business technical and environmental compliance assistance program.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) Puerto Rico § 52.2732 Small business technical and environmental compliance assistance program. On November 16, 1992, the Puerto Rico Environmental Quality Board submitted a plan for the... Assistance Program for incorporation in the Puerto Rico state implementation plan. This plan meets the...

40 CFR 52.2732 - Small business technical and environmental compliance assistance program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) Puerto Rico § 52.2732 Small business technical and environmental compliance assistance program. On November 16, 1992, the Puerto Rico Environmental Quality Board submitted a plan for the... Assistance Program for incorporation in the Puerto Rico state implementation plan. This plan meets the...

40 CFR 52.2732 - Small business technical and environmental compliance assistance program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) Puerto Rico § 52.2732 Small business technical and environmental compliance assistance program. On November 16, 1992, the Puerto Rico Environmental Quality Board submitted a plan for the... Assistance Program for incorporation in the Puerto Rico state implementation plan. This plan meets the...

40 CFR 123.45 - Noncompliance and program reporting by the Director.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) WATER PROGRAMS STATE PROGRAM REQUIREMENTS Transfer of Information and Permit Review § 123.45... schedule report for final compliance or a monitoring report. This applies when the permittee has failed to submit a final compliance schedule progress report, pretreatment report, or a Discharge Monitoring Report...

40 CFR 123.45 - Noncompliance and program reporting by the Director.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) WATER PROGRAMS STATE PROGRAM REQUIREMENTS Transfer of Information and Permit Review § 123.45... schedule report for final compliance or a monitoring report. This applies when the permittee has failed to submit a final compliance schedule progress report, pretreatment report, or a Discharge Monitoring Report...

40 CFR 123.45 - Noncompliance and program reporting by the Director.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) WATER PROGRAMS STATE PROGRAM REQUIREMENTS Transfer of Information and Permit Review § 123.45... schedule report for final compliance or a monitoring report. This applies when the permittee has failed to submit a final compliance schedule progress report, pretreatment report, or a Discharge Monitoring Report...

40 CFR 123.45 - Noncompliance and program reporting by the Director.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) WATER PROGRAMS STATE PROGRAM REQUIREMENTS Transfer of Information and Permit Review § 123.45... schedule report for final compliance or a monitoring report. This applies when the permittee has failed to submit a final compliance schedule progress report, pretreatment report, or a Discharge Monitoring Report...

19 CFR 191.193 - Application procedure for compliance program.

Code of Federal Regulations, 2010 CFR

2010-04-01

... participation in the drawback compliance program. This includes any person, corporation or business entity that... part). The detail required in the application shall take into account the size and nature of the applicant's drawback program, the type of drawback claims filed, and the dollar value and volume of claims...

23 CFR 1200.26 - Non-compliance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS Implementation and Management of the Highway Safety Program § 1200.26 Non-compliance. Where a State is found to... special conditions for high-risk grantees and the enforcement procedures of 49 CFR part 18, or the...

77 FR 56845 - Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-14

... Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast AGENCY... with the Federal Select Agent Program. The purpose of this notice is to notify all interested parties... changes to the select agent regulations; occupational health, information and physical security; personnel...

36 CFR 9.85 - Environmental compliance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Environmental compliance. 9... MINERALS MANAGEMENT Alaska Mineral Resource Assessment Program § 9.85 Environmental compliance. Each AMRAP... sufficient information to the NPS to ensure appropriate compliance with the National Environmental Policy Act...

36 CFR 9.85 - Environmental compliance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Environmental compliance. 9... MINERALS MANAGEMENT Alaska Mineral Resource Assessment Program § 9.85 Environmental compliance. Each AMRAP... sufficient information to the NPS to ensure appropriate compliance with the National Environmental Policy Act...

45 CFR 1110.6 - Compliance information.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Compliance information. 1110.6 Section 1110.6... HUMANITIES GENERAL NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS § 1110.6 Compliance information. (a... the cooperation of recipients in obtaining compliance with this part and shall provide assistance and...

45 CFR 1175.170 - Compliance procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Compliance procedures. 1175.170 Section 1175.170... PROGRAMS OR ACTIVITIES CONDUCTED BY THE NATIONAL ENDOWMENT FOR THE HUMANITIES § 1175.170 Compliance...) The agency shall notify the Architectural and Transportation Barriers Compliance Board upon receipt of...

The principles of HACCP.

USDA-ARS?s Scientific Manuscript database

The Hazard Analysis and Critical Control Point (HACCP) food safety inspection program is utilized by both USDA Food Safety Inspection Service (FSIS) and FDA for many of the products they regulate. This science-based program was implemented by the USDA FSIS to enhance the food safety of meat and pou...

76 FR 51048 - Notice of Submission of Proposed Information Collection to OMB Ginnie Mae Mortgage-Backed...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

...-Backed Securities programs and to monitor performance and compliance with established rules and... issuers/customers in its Mortgage-Backed Securities programs and to monitor performance and compliance...

75 FR 61361 - Energy Conservation Program: Certification, Compliance, and Enforcement for Consumer Products and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

.... EERE-2010-BT-CE-0014] RIN 1904-AC24 Energy Conservation Program: Certification, Compliance, and Enforcement for Consumer Products and Commercial and Industrial Equipment Correction In proposed rule document...

78 FR 76628 - Pilot Program for Parallel Review of Medical Products; Extension of the Duration of the Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-18

...The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) (the Agencies) are announcing the extension of the ``Pilot Program for Parallel Review of Medical Products.'' The Agencies have decided to continue the program as currently designed for an additional period of 2 years from the date of publication of this notice.

Ecological Monitoring and Compliance Program 2015 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hall, Derek B.; Ostler, W. Kent; Anderson, David C.

The Ecological Monitoring and Compliance Program (EMAC), funded through the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO), monitors the ecosystem of the Nevada National Security Site (NNSS) and ensures compliance with laws and regulations pertaining to NNSS biota. This report summarizes the program’s activities conducted by National Security Technologies, LLC (NSTec), during calendar year 2015. Program activities included (a) biological surveys at proposed activity sites, (b) desert tortoise compliance, (c) ecosystem monitoring, (d) sensitive plant species monitoring, (e) sensitive and protected/regulated animal monitoring, and (f) habitat restoration monitoring. During 2015, all applicable laws, regulations, andmore » permit requirements were met, enabling EMAC to achieve its intended goals and objectives.« less

Ecological Monitoring and Compliance Program 2013 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hall, Derek B.; Anderson, David C.; Greger, Paul D.

The Ecological Monitoring and Compliance Program (EMAC), funded through the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO, formerly Nevada Site Office), monitors the ecosystem of the Nevada National Security Site (NNSS) and ensures compliance with laws and regulations pertaining to NNSS biota. This report summarizes the program’s activities conducted by National Security Technologies, LLC (NSTec), during calendar year 2013. Program activities included (a) biological surveys at proposed activity sites, (b) desert tortoise compliance, (c) ecosystem monitoring, (d) sensitive plant species monitoring, (e) sensitive and protected/regulated animal monitoring, and (f) habitat restoration monitoring. During 2013, allmore » applicable laws, regulations, and permit requirements were met, enabling EMAC to achieve its intended goals and objectives.« less

Ecological Monitoring and Compliance Program 2016 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hall, Derek; Perry, Jeanette; Ostler, W. Kent

The Ecological Monitoring and Compliance Program (EMAC), funded through the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO), monitors the ecosystem of the Nevada National Security Site (NNSS) and ensures compliance with laws and regulations pertaining to NNSS biota. This report summarizes the program’s activities conducted by National Security Technologies, LLC (NSTec), during calendar year 2016. Program activities included (a) biological surveys at proposed activity sites, (b) desert tortoise compliance, (c) ecosystem monitoring, (d) sensitive plant species monitoring, (e) sensitive and protected/regulated animal monitoring, and (f) habitat restoration monitoring. During 2016, all applicable laws, regulations, andmore » permit requirements were met, enabling EMAC to achieve its intended goals and objectives.« less

Effect of Contract Compliance Rate to a Fourth-Generation Telehealth Program on the Risk of Hospitalization in Patients With Chronic Kidney Disease: Retrospective Cohort Study.

PubMed

Hung, Chi-Sheng; Lee, Jenkuang; Chen, Ying-Hsien; Huang, Ching-Chang; Wu, Vin-Cent; Wu, Hui-Wen; Chuang, Pao-Yu; Ho, Yi-Lwun

2018-01-24

Chronic kidney disease (CKD) is prevalent in Taiwan and it is associated with high all-cause mortality. We have shown in a previous paper that a fourth-generation telehealth program is associated with lower all-cause mortality compared to usual care with a hazard ratio of 0.866 (95% CI 0.837-0.896). This study aimed to evaluate the effect of renal function status on hospitalization among patients receiving this program and to evaluate the relationship between contract compliance rate to the program and risk of hospitalization in patients with CKD. We retrospectively analyzed 715 patients receiving the telehealth care program. Contract compliance rate was defined as the percentage of days covered by the telehealth service before hospitalization. Patients were stratified into three groups according to renal function status: (1) normal renal function, (2) CKD, or (3) end-stage renal disease (ESRD) and on maintenance dialysis. The outcome measurements were first cardiovascular and all-cause hospitalizations. The association between contract compliance rate, renal function status, and hospitalization risk was analyzed with a Cox proportional hazards model with time-dependent covariates. The median follow-up duration was 694 days (IQR 338-1163). Contract compliance rate had a triphasic relationship with cardiovascular and all-cause hospitalizations. Patients with low or very high contract compliance rates were associated with a higher risk of hospitalization. Patients with CKD or ESRD were also associated with a higher risk of hospitalization. Moreover, we observed a significant interaction between the effects of renal function status and contract compliance rate on the risk of hospitalization: patients with ESRD, who were on dialysis, had an increased risk of hospitalization at a lower contract compliance rate, compared with patients with normal renal function or CKD. Our study showed that there was a triphasic relationship between contract compliance rate to the telehealth program and risk of hospitalization. Renal function status was associated with risk of hospitalization among these patients, and there was a significant interaction with contract compliance rate. ©Chi-Sheng Hung, Jenkuang Lee, Ying-Hsien Chen, Ching-Chang Huang, Vin-Cent Wu, Hui-Wen Wu, Pao-Yu Chuang, Yi-Lwun Ho. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.01.2018.

Propylthiouracil

MedlinePlus

... produces too much thyroid hormone, speeding the body's metabolism, and causing certain symptoms) in adults and children ... to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( ...

Review of Usnic Acid and Usnea Barbata Toxicity

PubMed Central

Guo, Lei; Shi, Qiang; Fang, Jia-Long; Mei, Nan; Ali, A. Afshan; Lewis, Sherry M.; Leakey, Julian E.A.; Frankos, Vasilios H.

2017-01-01

Usnic acid is a prominent secondary lichen metabolite that has been used for various purposes worldwide. Crude extracts of usnic acid or pure usnic acid have been marketed in the United States as dietary supplements to aid in weight loss. The US Food and Drug Administration (FDA) received 21 reports of liver toxicity related to the ingestion of dietary supplements that contain usnic acid. This prompted the FDA to issue a warning about one such supplement, LipoKinetix, in 2001 (http://www.cfsan.fda.gov/~dms/ds-lipo.html). Subsequently, usnic acid and Usnea barbata lichen were nominated by the National Toxicology Program (NTP) for toxicity evaluations. At present, a toxicological evaluation of usnic acid is being conducted by the NTP. This review focuses on the recent findings of usnic acid-induced toxicities and their underlying mechanisms of action. PMID:19034791

10 CFR 490.802 - Eligibility for alternative compliance waiver.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Eligibility for alternative compliance waiver. 490.802 Section 490.802 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ALTERNATIVE FUEL TRANSPORTATION PROGRAM Alternative Compliance § 490.802 Eligibility for alternative compliance waiver. Any State subject to subpart C...

10 CFR 490.802 - Eligibility for alternative compliance waiver.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 3 2011-01-01 2011-01-01 false Eligibility for alternative compliance waiver. 490.802 Section 490.802 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ALTERNATIVE FUEL TRANSPORTATION PROGRAM Alternative Compliance § 490.802 Eligibility for alternative compliance waiver. Any State subject to subpart C...

10 CFR 490.802 - Eligibility for alternative compliance waiver.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 3 2014-01-01 2014-01-01 false Eligibility for alternative compliance waiver. 490.802 Section 490.802 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ALTERNATIVE FUEL TRANSPORTATION PROGRAM Alternative Compliance § 490.802 Eligibility for alternative compliance waiver. Any State subject to subpart C...

10 CFR 490.802 - Eligibility for alternative compliance waiver.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 3 2012-01-01 2012-01-01 false Eligibility for alternative compliance waiver. 490.802 Section 490.802 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ALTERNATIVE FUEL TRANSPORTATION PROGRAM Alternative Compliance § 490.802 Eligibility for alternative compliance waiver. Any State subject to subpart C...

10 CFR 490.802 - Eligibility for alternative compliance waiver.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 3 2013-01-01 2013-01-01 false Eligibility for alternative compliance waiver. 490.802 Section 490.802 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ALTERNATIVE FUEL TRANSPORTATION PROGRAM Alternative Compliance § 490.802 Eligibility for alternative compliance waiver. Any State subject to subpart C...

7 CFR 16.5 - Compliance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 1 2011-01-01 2011-01-01 false Compliance. 16.5 Section 16.5 Agriculture Office of the Secretary of Agriculture EQUAL OPPORTUNITY FOR RELIGIOUS ORGANIZATIONS § 16.5 Compliance. USDA agencies will monitor compliance with this part in the course of regular oversight of USDA programs. ...

45 CFR 1153.170 - Compliance procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Compliance procedures. 1153.170 Section 1153.170... PROGRAMS OR ACTIVITIES CONDUCTED BY THE NATIONAL ENDOWMENT FOR THE ARTS § 1153.170 Compliance procedures... and Transportation Barriers Compliance Board upon receipt of any complaint alleging that a building or...

7 CFR 16.5 - Compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 1 2010-01-01 2010-01-01 false Compliance. 16.5 Section 16.5 Agriculture Office of the Secretary of Agriculture EQUAL OPPORTUNITY FOR RELIGIOUS ORGANIZATIONS § 16.5 Compliance. USDA agencies will monitor compliance with this part in the course of regular oversight of USDA programs. ...

42 CFR 3.308 - Compliance reviews.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Compliance reviews. 3.308 Section 3.308 Public... ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.308 Compliance reviews. The Secretary may conduct compliance reviews to determine whether a respondent is complying with the applicable...

Exercise Compliance. A Data Documentation System.

ERIC Educational Resources Information Center

Scherf, Joanne; Franklin, Barry A.

1987-01-01

The Cardiovascular Fitness and Rehabilitation Program of Sinai Hospital of Detroit implemented an exercise compliance data documentation system in 1984 which is used in its outpatient gymnasium cardiac fitness and rehabilitation program. This documentation system is described. (MT)

Effects of Title IV of the Clean Air Act Amendments of 1990 on Electric Utilities: An Update, The

EIA Publications

1997-01-01

Describes the strategies used to comply with the Acid Rain Program in 1995, the effect of compliance on SO2 emissions levels, the cost of compliance, and the effects of the program on coal supply and demand. It updates and expands the EIA report, Electric Utility Phase I Acid Rain Compliance Strategies for the Clean Air Act Amendments of 1990.

An Evaluation of the High-Probability Instruction Sequence with and without Programmed Reinforcement for Compliance with High-Probability Instructions

ERIC Educational Resources Information Center

Zuluaga, Carlos A.; Normand, Matthew P.

2008-01-01

We assessed the effects of reinforcement and no reinforcement for compliance to high-probability (high-p) instructions on compliance to low-probability (low-p) instructions using a reversal design. For both participants, compliance with the low-p instruction increased only when compliance with high-p instructions was followed by reinforcement.…

Dutasteride

MedlinePlus

... alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate. ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Salsalate

MedlinePlus

... called salicylates. It works by stopping the body's production of a substance that causes pain, fever, and ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Glycopyrrolate

MedlinePlus

... of medications called anticholinergics. It decreases stomach acid production by blocking the activity of a certain natural ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Diflunisal

MedlinePlus

... called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Sulindac

MedlinePlus

... called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

75 FR 63845 - Medical Device User Fees; Public Meeting; Extension of Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

...] Medical Device User Fees; Public Meeting; Extension of Comment Period AGENCY: Food and Drug Administration... stakeholders on the Agency's medical user fee program and requested suggestions regarding the commitments FDA... interested stakeholders to discuss the Agency's medical user fee program and requested suggestions regarding...

Access to Experimental Cancer Drugs

Cancer.gov

An experimental drug has been tested in the lab and with animals and approved for testing in people by the FDA, but can’t yet be advertised, sold, or prescribed. Experimental drugs may be available through clinical trials or expanded access programs - learn more about these programs and how to talk to your doctor.

76 FR 68197 - Clinical Development Programs for Sedation Products; Public Workshop; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0547] Clinical Development Programs for Sedation Products; Public Workshop; Request for Comments AGENCY: Food and... clinically meaningful (e.g., subjective and objective assessments of memory, recall, anxiety, agitation, or...

77 FR 25024 - Certification of Compliance With Meal Requirements for the National School Lunch Program Under...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-27

... SNDA was conducted. Larger proportions of elementary schools met the standards for total fat and... Certification of Compliance With Meal Requirements for the National School Lunch Program Under the Healthy.... SUMMARY: This interim rule amends National School Lunch Program regulations to conform to requirements...

7 CFR 3052.510 - Audit findings.

Code of Federal Regulations, 2011 CFR

2011-01-01

... for the purpose of reporting an audit finding is in relation to a type of compliance requirement for a... type of compliance requirement for a major program or an audit objective identified in the compliance supplement. (3) Known questioned costs which are greater than $10,000 for a type of compliance requirement...

29 CFR 99.510 - Audit findings.

Code of Federal Regulations, 2011 CFR

2011-07-01

... for the purpose of reporting an audit finding is in relation to a type of compliance requirement for a... type of compliance requirement for a major program or an audit objective identified in the compliance supplement. (3) Known questioned costs which are greater than $10,000 for a type of compliance requirement...

38 CFR 41.510 - Audit findings.

Code of Federal Regulations, 2011 CFR

2011-07-01

... purpose of reporting an audit finding is in relation to a type of compliance requirement for a major... type of compliance requirement for a major program or an audit objective identified in the compliance supplement. (3) Known questioned costs, which are greater than $10,000, for a type of compliance requirement...

24 CFR 200.635 - Compliance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 2 2011-04-01 2011-04-01 false Compliance. 200.635 Section 200.635... GENERAL INTRODUCTION TO FHA PROGRAMS Affirmative Fair Housing Marketing Regulations § 200.635 Compliance... Department will enforce compliance through the procedures outlined in 24 CFR part 108. [37 FR 75, Jan. 5...

24 CFR 200.635 - Compliance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Compliance. 200.635 Section 200.635... GENERAL INTRODUCTION TO FHA PROGRAMS Affirmative Fair Housing Marketing Regulations § 200.635 Compliance... Department will enforce compliance through the procedures outlined in 24 CFR part 108. [37 FR 75, Jan. 5...

Cromolyn Ophthalmic

MedlinePlus

... keratitis (a condition that causes swelling of the cornea [tissue in the front of the eye] that ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Ofloxacin Ophthalmic

MedlinePlus

... 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:// ...

Nepafenac Ophthalmic

MedlinePlus

... inflammatory drugs (NSAIDs). It works by stopping the production of certain natural substances that cause pain and ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Famotidine Injection

MedlinePlus

... the pancreas and small intestine that caused increased production of stomach acid). Famotidine injection is in a ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Ranitidine Injection

MedlinePlus

... the pancreas and small intestine that caused increased production of stomach acid). Ranitidine injection is in a ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

Ecological Monitoring and Compliance Program 2010 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hansen, D.J.; Anderson, D.C.; Hall, D.B.

The Ecological Monitoring and Compliance (EMAC) Program, funded through the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office (NNSA/NSO), monitors the ecosystem of the Nevada National Security Site (NNSS) and ensures compliance with laws and regulations pertaining to NNSS biota. This report summarizes the program’s activities conducted by National Security Technologies, LLC (NSTec), during calendar year 2010. Program activities included (a) biological surveys at proposed construction sites, (b) desert tortoise compliance, (c) ecosystem monitoring, (d) sensitive plant species monitoring, (e) sensitive and protected/regulated animal monitoring, (f) habitat restoration monitoring, and (g) monitoring of the Nonproliferation Test andmore » Evaluation Complex (NPTEC). During 2010, all applicable laws, regulations, and permit requirements were met, enabling EMAC to achieve its intended goals and objectives.« less

Ecological Monitoring and Compliance Program 2012 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hall, Derek B.; Anderson, David C.; Greger, Paul D.

The Ecological Monitoring and Compliance Program (EMAC), funded through the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO, formerly Nevada Site Office), monitors the ecosystem of the Nevada National Security Site (NNSS) and ensures compliance with laws and regulations pertaining to NNSS biota. This report summarizes the program’s activities conducted by National Security Technologies, LLC (NSTec), during calendar year 2012. Program activities included (a) biological surveys at proposed construction sites, (b) desert tortoise compliance, (c) ecosystem monitoring, (d) sensitive plant species monitoring, (e) sensitive and protected/regulated animal monitoring, (f) habitat restoration monitoring, and (g) monitoring ofmore » the Nonproliferation Test and Evaluation Complex (NPTEC). During 2012, all applicable laws, regulations, and permit requirements were met, enabling EMAC to achieve its intended goals and objectives.« less

Ecological Monitoring and Compliance Program 2009 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hansen, J. Dennis; Anderson, David C.; Hall, Derek B.

The Ecological Monitoring and Compliance Program (EMAC), funded through the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office, monitors the ecosystem of the Nevada Test Site and ensures compliance with laws and regulations pertaining to NTS biota. This report summarizes the program’s activities conducted by National Security Technologies, LLC, during calendar year 2009. Program activities included (a) biological surveys at proposed construction sites, (b) desert tortoise compliance, (c) ecosystem mapping and data management, (d) sensitive plant species monitoring, (e) sensitive and protected/regulated animal monitoring, (f) habitat monitoring, (g) habitat restoration monitoring, and (h) monitoring of the Nonproliferationmore » Test and Evaluation Complex. During 2009, all applicable laws, regulations, and permit requirements were met, enabling EMAC to achieve its intended goals and objectives.« less

Corporate compliance: critical to organizational success.

PubMed

Cantone, L

1999-01-01

Operation Restore Trust (ORT) has focused increased governmental attention on health care fraud and abuse activities, making it more costly to be noncompliant, and thus has led to significant behavioral changes within the health care industry. Initially five states (California, Florida, Illinois, New York, & Texas) were included in the 1997 ORT pilot program. This has been expanded to include Arizona, Colorado, Georgia, Louisiana, Massachusetts, Missouri, New Jersey, Ohio, Pennsylvania, Tennessee, Virginia, and Washington. The author presents a road map for developing of a compliance program that includes suggested strategies for staff training in anticipation of heightened scrutiny of compliance standards and procedures. Effective Corporate Compliance Programs (CCPs) should include policies and procedures and monitoring systems that can provide reasonable assurance that fraud, abuse, and systematic billing errors are detected in a timely manner.

40 CFR 160.12 - Statement of compliance or non-compliance.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS General Provisions § 160.12 Statement of compliance or... accordance with this part; or (b) A statement describing in detail all differences between the practices used...

77 FR 74668 - Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-17

...; Formerly Docket No. 2004D-0499] Compliance Policy Guide; Radiofrequency Identification Feasibility Studies... extending the expiration date of compliance policy guide (CPG) Sec. 400.210 entitled ``Radiofrequency... 74669

The FDA's decision-making process: isn't it time to temper the principle of protective paternalism?

PubMed

Brandt, Lawrence J

2008-05-01

The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision.

Determination of radionuclides in foods from Minsk, Belarus, from Chernobyl to the present

NASA Astrophysics Data System (ADS)

Baratta, E. J.

2003-01-01

The U.S. Food and Drug Administration (FDA) are responsible for the wholesomeness of the food supply in the United States (US). The FDA has been monitoring the food supply in the United States for radioactivity since 1961, because of the Fallout generated by above the ground testing in the early 60’s. This Radionuclide in Foods Program is maintained to allow the FDA to respond to any nuclear emergency that may affect the food supply. The Three Mile Island incident in 1979 was one of these. In 1986 the Chernobyl incident occurred. As a result, the FDA began extensive monitoring of imported foods, especially those from Europe. One of its sister agencies has personnel in the areas effected by the latter incident and requested that the FDA analyze selected food samples from these places. Since that time, they have requested on a periodic basis, selected food samples be analysed. One such city was Minsk in Belarus. This paper will discuss the radionuclides of interest such as iodine-131, cesium-134/137, strontium-90, ruthenium-106 and other short-lived ones. It will discuss the types of foods sampled and the methodology used in determining the concentrations found in these items. The results will be compared to the permissible levels allowed in the US. In addition it will show the lower limits of detection for each of the radionuclides of interest.

Pediatric surgery fellowship compliance to the 80-hour work week.

PubMed

Ladd, Alan P

2006-04-01

The goal of this study was to determine the compliance of pediatric surgery fellowships with Accreditation Council for Graduate Medical Education (ACGME) duty hour restrictions while confronting a reduced resident workforce. An evaluation of training programs was performed by surveying pediatric surgery fellows on aspects of work hours, ACGME guideline compliance, operative case volume, employment of physician extenders, and didactic education. A 74% survey response rate was achieved. Of the respondents, 95% felt fully aware of ACGME guidelines. Although 95% of programs had mechanisms for compliance in place, only 45% of fellows felt compliant. Median work hours were 80 to 90 hours per week. Although subordinate residents were felt to obtain better compliance (>86%), only 69% of fellows perceived greater service commitment as a result. No impact on volume of operative cases was perceived. Of the programs, 89% employed physician extenders and 55% used additional fellows, but no overall effect on fellow work hours was evident. Fellows did not identify an improvement in the quality of clinical fellowships with guideline implementation. A minority of fellows comply with ACGME guidelines. Vigilance of duty hour tracking correlates to better compliance. A shift of patient care to fellows is perceived. Use of support personnel did not significantly aid compliance.

Privacy Impact Assessment for the External Compliance Program Discrimination Complaint Files

EPA Pesticide Factsheets

The External Compliance Program Discrimination Complaint Files System collects information on administrative complaints. Learn how this data will be collected in the system, how it will be used, access to the data, and the purpose of data collection.

12 CFR 268.710 - Compliance procedures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... RULES REGARDING EQUAL OPPORTUNITY Prohibition Against Discrimination in Board Programs and Activities Because of Physical or Mental Disability § 268.710 Compliance procedures. (a) Applicability. Except as..., applies to all allegations of discrimination on the basis of a disability in programs or activities...

41 CFR 60-1.2 - Administrative responsibility.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Public Contracts OFFICE OF FEDERAL CONTRACT COMPLIANCE PROGRAMS, EQUAL EMPLOYMENT OPPORTUNITY, DEPARTMENT... the Deputy Assistant Secretary, Office of Federal Contract Compliance Programs, Employment Standards Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. [43 FR 49240, Oct...

41 CFR 60-1.2 - Administrative responsibility.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Public Contracts OFFICE OF FEDERAL CONTRACT COMPLIANCE PROGRAMS, EQUAL EMPLOYMENT OPPORTUNITY, DEPARTMENT... the Deputy Assistant Secretary, Office of Federal Contract Compliance Programs, Employment Standards Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. [43 FR 49240, Oct...

41 CFR 60-1.2 - Administrative responsibility.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Public Contracts OFFICE OF FEDERAL CONTRACT COMPLIANCE PROGRAMS, EQUAL EMPLOYMENT OPPORTUNITY, DEPARTMENT... the Deputy Assistant Secretary, Office of Federal Contract Compliance Programs, Employment Standards Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. [43 FR 49240, Oct...

12 CFR 268.710 - Compliance procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... RULES REGARDING EQUAL OPPORTUNITY Prohibition Against Discrimination in Board Programs and Activities Because of Physical or Mental Disability § 268.710 Compliance procedures. (a) Applicability. Except as..., applies to all allegations of discrimination on the basis of a disability in programs or activities...

Development of Greenhouse Gas Emissions Model (GEM) for Heavy- & Medium-Duty Vehicle Compliance

EPA Science Inventory

A regulatory vehicle simulation program was designed for determining greenhouse gas (GHG) emissions and fuel consumption by estimating the performance of technologies, verifying compliance with the regulatory standards and estimating the overall benefits of the program.

Safety assurance and compliance program (SACP) : accomplishments for CY 2001

DOT National Transportation Integrated Search

2002-08-01

This recent research report by the Federal Railroad Administration (FRA), posted online, provides ease of access to information on the Safety Assurance and Compliance Program. The FRA promotes and helps ensure the safety of the nation's railroad indu...

The new hospice compliance plan: defining and addressing risk areas. Part 3.

PubMed

Jones, D H; Woods, K

2000-07-01

The recently released OIG guidelines to ensure compliance with federal and state statutes, rules, and regulations, and private-payor health care program requirements provide a blueprint for developing such programs. This is the last of three installments that focus specifically on the 28 risk areas identified in the guidance and offer strategies for incorporating them in a hospice compliance program. The authors have organized the 28 risk areas under 9 topic domains to simplify the task of tackling the guidance. This article covers the areas of nursing home care, marketing, and Conditions of Participation.

Summary of development and recommendations for a quality assurance program for the procurement and manufacture of urban mass transit operating equipment and systems

NASA Technical Reports Server (NTRS)

Witkin, S. A.

1976-01-01

A viable quality program for the urban mass transit industry, and a management approach to ensure compliance with the program are outlined. Included are: (1) a set of guidelines for quality assurance to be imposed on transit authorities, and a management approach to ensure compliance with them; (2) a management approach to be used by the transit authorities (properties) for assuring compliance with the QA guidelines; and (3) quality assurance guidelines to be imposed by properties and umta for procurement of hardware and systems.

Determination of non-volatile radiolytic compounds in ethylene co-vinyl alcohol

NASA Astrophysics Data System (ADS)

Kothapalli, A.; Sadler, G.

2003-08-01

The use of ionizing radiation on food contact polymers is increasing due to the critical role of the package in holding or containing the irradiated foods [Food Add. Contam. 18(6) (2001) 475]. Irradiation benefits the food if properly applied and the food is pre-packaged prior to irradiation to protect it from subsequent recontamination. The United States Food and Drug Administration (USFDA) has approved the use of ionizing radiation within the dosage range of 0-60 kGy on limited films since the 1960s [USFDA 21CFR 179.45]. The obstacle in the way of approval of additional polymers is that FDA fears that these materials may undergo changes during irradiation producing toxic radiolytic fragments. Ethylene co-vinyl alcohol (EVOH), which is often used in food applications, is not approved by the FDA for pre-packaged irradiated foods. The present work examines the non-volatile radiolytic compounds, which may be formed due to exposure to gamma irradiation at the dosage levels of 3 and 10 kGy versus a non-radiated control. Irradiated EVOH is subjected to extraction with 95:5 ethanol and water (by volume) as the food simulating solvent (FSS) for a period of 10 days at 40 °C, which models the amount of radiolytic compound a food would extract in 1 year [USFDA Chemistry Requirement for Food Contact Notification]. The FSS is then analyzed for the presence of non-volatile compounds using advanced liquid chromatographic techniques. The chromatograms obtained from different dosages show that non-volatile radiolytic compounds are not formed in EVOH and it would, therefore be in compliance with safety demands of USFDA [Available at: http://www.cfsan.fda.gov/~dms/opa-guid.html#ref and http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1].

Simvastatin prescribing patterns before and after FDA dosing restrictions: a retrospective analysis of a large healthcare claims database.

PubMed

Tuchscherer, Rhianna M; Nair, Kavita; Ghushchyan, Vahram; Saseen, Joseph J

2015-02-01

Muscle-related events, or myopathies, are a commonly reported adverse event associated with statin use. In June 2011, the US FDA released a Drug Safety Communication that provided updated product labeling with dosing restrictions for simvastatin to minimize the risk of myopathies. Our objective was to describe prescribing patterns of simvastatin in combination with medications known to increase the risk of myopathies following updated product labeling dosing restrictions in June 2011. A retrospective observational analysis was carried out, in which administrative claims data were utilized to identify prescribing patterns of simvastatin in combination with calcium channel blockers (CCBs) and other pre-specified drug therapies. Prescribing patterns were analyzed on a monthly basis 24 months prior to and 9 months following product label changes. Incidence of muscle-related events was also analyzed. In June 2011, a total of 60% of patients with overlapping simvastatin-CCB claims and 94% of patients with overlapping simvastatin-non-CCB claims were prescribed an against-label combination. As of March 2012, a total of 41% and 93% of patients continued to be prescribed against-label simvastatin-CCB and simvastatin-non-CCB combinations, respectively. The most commonly prescribed dose of simvastatin was 20 mg (39%). Against-label combinations were most commonly prescribed at a simvastatin dose of 40 mg (56%). Amlodipine was the most commonly prescribed CCB in combination with simvastatin (70%) and the most common CCB prescribed against-label (67%). Despite improvements in prescribing practices, many patients are still exposed to potentially harmful simvastatin combinations. Aggressive changes in simvastatin prescribing systems and processes are needed to improve compliance with FDA labeling to improve medication and patient safety.

Animation of Antimicrobial Resistance

MedlinePlus Videos and Cool Tools

... 23/2018 Note: If you need help accessing information in different file formats, see Instructions for Downloading ... Flickr FDA Archive Combination Products Advisory Committees Regulatory Information Safety Emergency Preparedness International Programs News & Events Training & ...

Azelaic Acid Topical

MedlinePlus

... the bacteria that infect pores and by decreasing production of keratin, a natural substance that can lead ... send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http:// ...

40 CFR 97.524 - Compliance with TR NOX Ozone Season emissions limitation.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 22 2012-07-01 2012-07-01 false Compliance with TR NOX Ozone Season... TR NOX Ozone Season Trading Program § 97.524 Compliance with TR NOX Ozone Season emissions limitation. (a) Availability for deduction for compliance. TR NOX Ozone Season allowances are available to be...

40 CFR 97.524 - Compliance with TR NOX Ozone Season emissions limitation.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 22 2013-07-01 2013-07-01 false Compliance with TR NOX Ozone Season... TR NOX Ozone Season Trading Program § 97.524 Compliance with TR NOX Ozone Season emissions limitation. (a) Availability for deduction for compliance. TR NOX Ozone Season allowances are available to be...

40 CFR 97.524 - Compliance with TR NOX Ozone Season emissions limitation.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 21 2014-07-01 2014-07-01 false Compliance with TR NOX Ozone Season... TR NOX Ozone Season Trading Program § 97.524 Compliance with TR NOX Ozone Season emissions limitation. (a) Availability for deduction for compliance. TR NOX Ozone Season allowances are available to be...

10 CFR 851.4 - Compliance order.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Compliance order. 851.4 Section 851.4 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM General Provisions § 851.4 Compliance order. (a) The Secretary... effectiveness of a Compliance Order unless the Secretary issues an order to that effect. (d) A copy of the...

50 CFR 85.48 - Compliance with Federal laws, regulations, and policies.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 50 Wildlife and Fisheries 9 2014-10-01 2014-10-01 false Compliance with Federal laws, regulations... VESSEL ACT GRANT PROGRAM Conditions on Use/Acceptance of Funds § 85.48 Compliance with Federal laws... compliance with all applicable Federal laws, regulations, and policies. This is done by submitting an...

50 CFR 85.48 - Compliance with Federal laws, regulations, and policies.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false Compliance with Federal laws, regulations... VESSEL ACT GRANT PROGRAM Conditions on Use/Acceptance of Funds § 85.48 Compliance with Federal laws... compliance with all applicable Federal laws, regulations, and policies. This is done by submitting an...

50 CFR 85.48 - Compliance with Federal laws, regulations, and policies.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 50 Wildlife and Fisheries 9 2012-10-01 2012-10-01 false Compliance with Federal laws, regulations... VESSEL ACT GRANT PROGRAM Conditions on Use/Acceptance of Funds § 85.48 Compliance with Federal laws... compliance with all applicable Federal laws, regulations, and policies. This is done by submitting an...

50 CFR 85.48 - Compliance with Federal laws, regulations, and policies.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 50 Wildlife and Fisheries 9 2013-10-01 2013-10-01 false Compliance with Federal laws, regulations... VESSEL ACT GRANT PROGRAM Conditions on Use/Acceptance of Funds § 85.48 Compliance with Federal laws... compliance with all applicable Federal laws, regulations, and policies. This is done by submitting an...

34 CFR 75.731 - Records related to compliance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 1 2014-07-01 2014-07-01 false Records related to compliance. 75.731 Section 75.731... Responsibilities of a Grantee? Records § 75.731 Records related to compliance. A grantee shall keep records to show its compliance with program requirements. (Authority: 20 U.S.C. 1221e-3 and 3474) ...

A Strategy for Combining the Pollution Prevention Opportunity Assessment with the Environmental Compliance Assessment and Management Program

DTIC Science & Technology

1993-09-01

reductions occur, all government agencies will be faced with a need to streamline their programs and reduce their program implemetation and compliance costs. A...IRP) 14. Does the insta~lation cunuvtly have any designated IRP sites? IS. If ERP sites am preent, does the installanion maintain documentation of

Peer Assessment and Compliance Review (PACR) Innovative Strategies Report. California Court Appointed Special Advocates (CASA) Programs

ERIC Educational Resources Information Center

Macro, Bronwen; Huang, Lee Ann

2005-01-01

This report focuses on the innovative strategies study component of the Peer Assessment and Compliance Review (PACR) project. California (Court Appointed Special Advocates) CASA programs have developed many innovative strategies to serve children in their communities. At each of the programs visited during the PACR project, the team identified at…

7 CFR 1484.74 - How is Cooperator program compliance monitored?

Code of Federal Regulations, 2014 CFR

2014-01-01

... compliance monitored? (a) The Compliance Review Staff (CRS), FAS, performs periodic on-site reviews of... Cooperator do not supplant private or U.S. industry funds or contributions pursuant to § 1550.20(a)(14), FAS...

7 CFR 1484.74 - How is Cooperator program compliance monitored?

Code of Federal Regulations, 2013 CFR

2013-01-01

... compliance monitored? (a) The Compliance Review Staff (CRS), FAS, performs periodic on-site reviews of... Cooperator do not supplant private or U.S. industry funds or contributions pursuant to § 1550.20(a)(14), FAS...

7 CFR 1484.74 - How is Cooperator program compliance monitored?

Code of Federal Regulations, 2012 CFR

2012-01-01

... compliance monitored? (a) The Compliance Review Staff (CRS), FAS, performs periodic on-site reviews of... Cooperator do not supplant private or U.S. industry funds or contributions pursuant to § 1550.20(a)(14), FAS...

Integrated Compliance Information System (ICIS)

EPA Pesticide Factsheets

The purpose of ICIS is to meet evolving Enforcement and Compliance business needs for EPA and State users by integrating information into a single integrated data system that supports both management and programmatic requirements of the Enforcement and Compliance programs.

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.

PubMed

Hicks, Karen A; Mahaffey, Kenneth W; Mehran, Roxana; Nissen, Steven E; Wiviott, Stephen D; Dunn, Billy; Solomon, Scott D; Marler, John R; Teerlink, John R; Farb, Andrew; Morrow, David A; Targum, Shari L; Sila, Cathy A; Hai, Mary T Thanh; Jaff, Michael R; Joffe, Hylton V; Cutlip, Donald E; Desai, Akshay S; Lewis, Eldrin F; Gibson, C Michael; Landray, Martin J; Lincoff, A Michael; White, Christopher J; Brooks, Steven S; Rosenfield, Kenneth; Domanski, Michael J; Lansky, Alexandra J; McMurray, John J V; Tcheng, James E; Steinhubl, Steven R; Burton, Paul; Mauri, Laura; O'Connor, Christopher M; Pfeffer, Marc A; Hung, H M James; Stockbridge, Norman L; Chaitman, Bernard R; Temple, Robert J

2018-02-27

This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the US Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials. © 2018 American Heart Association, Inc.

Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership.

PubMed

Stang, Paul E; Ryan, Patrick B; Racoosin, Judith A; Overhage, J Marc; Hartzema, Abraham G; Reich, Christian; Welebob, Emily; Scarnecchia, Thomas; Woodcock, Janet

2010-11-02

The U.S. Food and Drug Administration (FDA) Amendments Act of 2007 mandated that the FDA develop a system for using automated health care data to identify risks of marketed drugs and other medical products. The Observational Medical Outcomes Partnership is a public-private partnership among the FDA, academia, data owners, and the pharmaceutical industry that is responding to the need to advance the science of active medical product safety surveillance by using existing observational databases. The Observational Medical Outcomes Partnership's transparent, open innovation approach is designed to systematically and empirically study critical governance, data resource, and methodological issues and their interrelationships in establishing a viable national program of active drug safety surveillance by using observational data. This article describes the governance structure, data-access model, methods-testing approach, and technology development of this effort, as well as the work that has been initiated.

Aristolochic Acids

MedlinePlus

... a full list, see the FDA website at https: / / go. usa. gov/ xN66S. Contact the manufacturer or ... I go for more information? National Toxicology Program https: / / ntp. niehs. nih. gov/ go/ roc The Report ...

Additional Research Opportunities | Cancer Prevention Fellowship Program

Cancer.gov

NCI-FDA Joint Training in Cancer Prevention Cancer Prevention Fellows are eligible to participate in Track 4 of the Interagency Oncology Task Force Fellowship program—offered as a partnership of the National

40 CFR 122.47 - Schedules of compliance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Schedules of compliance. 122.47 Section 122.47 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS EPA ADMINISTERED PERMIT PROGRAMS: THE NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM Permit Conditions § 122.47...

40 CFR 122.47 - Schedules of compliance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 22 2011-07-01 2011-07-01 false Schedules of compliance. 122.47 Section 122.47 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS EPA ADMINISTERED PERMIT PROGRAMS: THE NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM Permit Conditions § 122.47...

Environmental regulations: Technical reference manual TRM 016.01, September 15, 1995

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1995-09-15

This TRM is divided into two primary sections. The first section entitled Environmental Programs provides a synopsis of each environmental Act (Federal Law). The second section of the TRM is entitled Environmental Operations. This section is in effect the nuts and bolts of the regulatory compliance programs. In this section, the program manager can reference specific requirements which will aid in structuring the compliance program.

76 FR 44014 - Generic Drug User Fee; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

...] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS... development of a generic drug user fee program. A user fee program could provide necessary supplemental... generic drug user fees. New legislation would be required for FDA to establish and collect user fees for...

76 FR 65909 - Medicare and Medicaid Program; Regulatory Provisions To Promote Program Efficiency, Transparency...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... commonly found in other medical facilities, for example, cooking, anesthesia, paint shops, or piped-in... Part A and Part B claims appeals. In 2003, the Medicare Prescription Drug, Improvement, and... BIPA. The Food and Drug Administration's (FDA) categorization of a product as a category A device is...

75 FR 76472 - Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0602] Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for Biosimilar and Interchangeable Biological Product Applications; Request for Notification of Stakeholder Intention To Participate...

77 FR 37055 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... Request; Secure Supply Chain Pilot Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice... identified with the title Secure Supply Chain Pilot Program. Also include the FDA docket number found in... following proposed collection of information to OMB for review and clearance: ``Secure Supply Chain Pilot...

78 FR 11204 - Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-15

...] Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I; Draft Guidance... announcing the availability of the draft guidance entitled ``Accreditation and Reaccreditation Process for... Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), requires FDA...

78 FR 20924 - Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0248... Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... sponsors of investigational new drug (IND) applications to participate in a pilot evaluation program for...

78 FR 67369 - National Vaccine Injury Compensation Program: Addition to the Vaccine Injury Table to Include All...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... Vaccine Injury Compensation Program: Addition to the Vaccine Injury Table to Include All Vaccines Against...) announces that all FDA- approved vaccines against seasonal influenza are covered under the National Vaccine... individuals who have been injured by covered childhood vaccines. Prior to this publication, trivalent...

A STUDY TO EVALUATE THE LEVELS OF DIOXIN-LIKE COMPOUNDS IN DAIRY FEEDS IN THE U.S.

EPA Science Inventory

The Environmental Protection Agency (EPA), in cooperation with USDA and the US Food and Drug Administration (FDA), has undertaken a program to study the presence of dioxin-like compounds in animal feeds. Two phases of this program have been completed, and this paper reports on t...

New Jersey's Emergency Retrovir Reimbursement Program (ERRP).

ERIC Educational Resources Information Center

Conviser, Richard; And Others

In 1987 Congress made available a one-time, 1-year emergency appropriation to pay for Food and Drug Administration (FDA)-approved life-sustaining drugs for people with Acquired Immune Deficiency Syndrome (AIDS). New Jersey received $1.5 million from this program for antiviral drugs for low-income people with AIDS and AIDS Related Complex lacking…

State Compliance Monitoring Expectations | ECHO | US EPA

EPA Pesticide Factsheets

EPA sets national goals for how frequently facilities should be evaluated by the authorized enforcement agency for three programs included in ECHO (Clean Air Act, Clean Water Act, and Resource Conservation and Recovery Act). EPA develops Compliance Monitoring Strategies (CMSs) to ensure that the regulated facilities across the country are evaluated for compliance on a regular basis. Information on CMSs, evaluations (such as on-site inspections), and inspection frequency goals that are defined by each program is included.

The Apollo Accreditation Program: A web-based Joint Commission International standards compliance management tool.

PubMed

Dewan, Shaveta; Sibal, Anupam; Uberoi, R S; Kaur, Ishneet; Nayak, Yogamaya; Kar, Sujoy; Loria, Gaurav; Yatheesh, G; Balaji, V

2014-01-01

Creating and implementing processes to deliver quality care in compliance with accreditation standards is a challenging task but even more daunting is sustaining these processes and systems. There is need for frequent monitoring of the gap between the expected level of care and the level of care actually delivered so as to achieve consistent level of care. The Apollo Accreditation Program (AAP) was implemented as a web-based single measurable dashboard to display, measure and compare compliance levels for established standards of care in JCI accredited hospitals every quarter and resulted in an overall 15.5% improvement in compliance levels over one year.

Practitioner Perceptions of Patients Wearing Decorative Contact Lenses Purchased Through Unauthorized Sellers.

PubMed

Gaiser, Hilary; Ho, Connie; Janier, Nicole; Wee, Amy; Johnson, Catherine; Watanabe, Ronald

2017-03-01

To describe practitioner experiences regarding ocular complications in patients wearing decorative contact lenses, and to investigate the compliance of unauthorized distributors of decorative contact lenses to current Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulations. Also, to provide data to support a more targeted public health approach to reducing the incidence of illegal contact lens sales and associated ocular complications. An institutional review board-approved online survey was distributed through mass email to a list of 98 optometrists in the Boston, MA area. Concurrently, an empirical evaluation of independent, online decorative contact lens sellers who were not associated with FDA-approved contact lens manufacturers was performed to determine their adherence to FDA and FTC guidelines. The first 18 noncoincidental websites that resulted from a Google search for "costume contact lens sellers" and "cosmetic contact lens sellers" were examined as to the brands and parameters of lenses being sold, whether or not a valid prescription was required or verified, and if consumer education was provided. Twenty-two optometrists completed the online survey. Seventy-seven percent of respondents reported having patients with complications from decorative contact lenses that were purchased both legally and illegally. The most common age group for complications was 18 to 25 years (61%). One third of complications were seen in first-time lens wearers, half of whom never received proper care instructions or were unaware that care instructions existed. One quarter of the lenses were purchased illegally with unlicensed stores being the most common place of purchase. Of the 18 online sites examined, 72% of sellers failed to adhere to FTC and FDA regulations. A significant number of individuals who obtain contact lenses illegally from unauthorized sources are young adults. Most unauthorized sellers reviewed did not adhere to the proper protocol for selling contact lenses or instruct their customers on proper lens wear and care. A significant percentage of optometrists responding to the survey reported complications associated with contact lenses purchased through unauthorized sources, suggesting that the risk of contact lens-related complications increases when the lenses are purchased from one of these sources.

Improving the performance of US Environmental Protection Agency Method 300.1 for monitoring drinking water compliance.

PubMed

Wagner, Herbert P; Pepich, Barry V; Hautman, Daniel P; Munch, David J

2003-09-05

In 1998, the United States Environmental Protection Agency (EPA) promulgated the maximum contaminant level (MCL) for bromate in drinking water at 10 microg/l, and the method for compliance monitoring of bromate in drinking water was established under Stage 1 of the Disinfectants/Disinfection By-Products Rule (D/DBP) as EPA Method 300.1. In January 2002, the United States Food and Drug Administration (FDA) regulated the bromate concentration in bottled waters at 10 microg/l. EPA anticipates proposing additional methods, which have improved performance for bromate monitoring, in addition to EPA Method 300.1, in the Stage 2 DBP Rule. Until the Stage 2 Rule is promulgated, EPA Method 300.1 will continue to be the only method approved for compliance monitoring of bromate. This manuscript describes the work completed at EPA's Technical Support Center (TSC) to assess the performance of recently developed suppressor technologies toward improving the trace level performance of EPA Method 300.1, specifically for the analysis of trace levels of bromate in high ionic matrices. Three different types of Dionex suppressors were evaluated. The baseline noise, return to baseline after the water dip, detection limits, precision and accuracy, and advantages/disadvantages of each suppressor are discussed. Performance data for the three different suppressors indicates that chemical suppression of the eluent, using the AMMS III suppressor, is the most effective means to reduce baseline noise, resulting in the best resolution and the lowest bromate detection limits, even when a high ionic matrix is analyzed. Incorporation of the AMMS III suppressor improves the performance of EPA Method 300.1 at and below 5.0 microg/l and is a quick way for laboratories to improve their bromate compliance monitoring.

An educational intervention to improve hand hygiene compliance in Vietnam.

PubMed

Phan, Hang Thi; Tran, Hang Thi Thuy; Tran, Hanh Thi My; Dinh, Anh Pham Phuong; Ngo, Ha Thanh; Theorell-Haglow, Jenny; Gordon, Christopher J

2018-03-07

Hand hygiene compliance is the basis of infection control programs. In developing countries models to improve hand hygiene compliance to reduce healthcare acquired infections are required. The aim of this study was to determine hand hygiene compliance following an educational program in an obstetric and gynecological hospital in Vietnam. Health care workers from neonatal intensive care, delivery suite and a surgical ward from Hung Vuong Hospital, Ho Chi Minh City, Vietnam undertook a 4-h educational program targeting hand hygiene. Compliance was monitored monthly for six months following the intervention. Hand hygiene knowledge was assessed at baseline and after six months of the study. There were 7124 opportunities over 370 hand hygiene recording sessions with 1531 opportunities at baseline and 1620 at 6 months following the intervention. Hand hygiene compliance increased significantly from baseline across all sites (43.6% [95% Confidence interval CI: 41.1-46.1] to 63% [95% CI: 60.6-65.3]; p < 0.0001). Health care worker hand hygiene compliance increased significantly after intervention (p < 0.0001). There were significant improvements in knowledge scores from baseline to 2 months post educational intervention with mean difference standard deviations (SD): 1.5 (2.5); p < 0.001). A simple educational model was implemented in a Vietnamese hospital that revealed good hand hygiene compliance for an extended period of time. Hand hygiene knowledge increased during the intervention. This hand hygiene model could be used in developing countries were resources are limited.

40 CFR 145.12 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., independent of information supplied by regulated persons, compliance or noncompliance with applicable program... information submitted by permittees and other regulated persons in reporting forms and other forms supplying... “chain of custody” procedures] that will produce evidence admissible in an enforcement proceeding or in...

40 CFR 145.12 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., independent of information supplied by regulated persons, compliance or noncompliance with applicable program... information submitted by permittees and other regulated persons in reporting forms and other forms supplying... “chain of custody” procedures] that will produce evidence admissible in an enforcement proceeding or in...

40 CFR 145.12 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., independent of information supplied by regulated persons, compliance or noncompliance with applicable program... information submitted by permittees and other regulated persons in reporting forms and other forms supplying... “chain of custody” procedures] that will produce evidence admissible in an enforcement proceeding or in...

40 CFR 123.26 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2013 CFR

2013-07-01

... information supplied by regulated persons, compliance or noncompliance with applicable program requirements... information submitted by permittees and other regulated persons in reporting forms and other forms supplying... a manner (e.g., using proper “chain of custody” procedures) that will produce evidence admissible in...

40 CFR 123.26 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2014 CFR

2014-07-01

... information supplied by regulated persons, compliance or noncompliance with applicable program requirements... information submitted by permittees and other regulated persons in reporting forms and other forms supplying... a manner (e.g., using proper “chain of custody” procedures) that will produce evidence admissible in...

40 CFR 123.26 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... information supplied by regulated persons, compliance or noncompliance with applicable program requirements... information submitted by permittees and other regulated persons in reporting forms and other forms supplying... a manner (e.g., using proper “chain of custody” procedures) that will produce evidence admissible in...

75 FR 50007 - Request for Certification of Compliance-Rural Industrialization Loan and Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... DEPARTMENT OF LABOR Employment and Training Administration Request for Certification of Compliance--Rural Industrialization Loan and Grant Program AGENCY: Employment and Training Administration, Labor. ACTION: Notice. SUMMARY: The Employment and Training Administration is issuing this notice to announce...

75 FR 54655 - Request for Certification of Compliance-Rural Industrialization Loan and Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

... DEPARTMENT OF LABOR Employment and Training Administration Request for Certification of Compliance--Rural Industrialization Loan and Grant Program AGENCY: Employment and Training Administration, Labor. ACTION: Notice. SUMMARY: The Employment and Training Administration is issuing this notice to announce...

75 FR 50006 - Request for Certification of Compliance-Rural Industrialization Loan and Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... DEPARTMENT OF LABOR Employment and Training Administration Request for Certification of Compliance--Rural Industrialization Loan and Grant Program AGENCY: Employment and Training Administration, Labor. ACTION: Notice. SUMMARY: The Employment and Training Administration is issuing this notice to announce...

78 FR 37584 - Request for Certification of Compliance-Rural Industrialization Loan and Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-21

... DEPARTMENT OF LABOR Employment and Training Administration Request for Certification of Compliance--Rural Industrialization Loan and Grant Program AGENCY: Employment and Training Administration, Labor. ACTION: Notice. SUMMARY: The Employment and Training Administration is issuing this notice to announce...

25 CFR 170.451 - Can IRR Program funds be used for archeological and environmental compliance?

Code of Federal Regulations, 2010 CFR

2010-04-01

... environmental compliance? 170.451 Section 170.451 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND AND WATER INDIAN RESERVATION ROADS PROGRAM Planning, Design, and Construction of Indian... the appropriate Secretary(s); and (d) Construction easements. Design ...

40 CFR 145.12 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., independent of information supplied by regulated persons, compliance or noncompliance with applicable program... information submitted by permittees and other regulated persons in reporting forms and other forms supplying... “chain of custody” procedures] that will produce evidence admissible in an enforcement proceeding or in...

40 CFR 145.12 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., independent of information supplied by regulated persons, compliance or noncompliance with applicable program... information submitted by permittees and other regulated persons in reporting forms and other forms supplying... “chain of custody” procedures] that will produce evidence admissible in an enforcement proceeding or in...

40 CFR 123.26 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... information supplied by regulated persons, compliance or noncompliance with applicable program requirements... information submitted by permittees and other regulated persons in reporting forms and other forms supplying... a manner (e.g., using proper “chain of custody” procedures) that will produce evidence admissible in...

40 CFR 123.26 - Requirements for compliance evaluation programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... information supplied by regulated persons, compliance or noncompliance with applicable program requirements... information submitted by permittees and other regulated persons in reporting forms and other forms supplying... a manner (e.g., using proper “chain of custody” procedures) that will produce evidence admissible in...

17 CFR 37.1501 - Chief compliance officer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... facility's self-regulatory program that is requested by the board of directors or the regulatory oversight... compliance office review, look-back, internal or external audit finding, self-reported error, or validated...) Supervising the swap execution facility's self-regulatory program with respect to trade practice surveillance...

75 FR 454 - Request for Certification of Compliance-Rural Industrialization Loan and Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-05

... DEPARTMENT OF LABOR Employment and Training Administration Request for Certification of Compliance--Rural Industrialization Loan and Grant Program AGENCY: Employment and Training Administration, Labor. ACTION: Notice. SUMMARY: The Employment and Training Administration is issuing this notice to announce...

Ecological Monitoring and Compliance Program Fiscal/Calendar Year 2004 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bechtel Nevada

2005-03-01

The Ecological Monitoring and Compliance program, funded through the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office, monitors the ecosystem of the Nevada Test Site and ensures compliance with laws and regulations pertaining to Nevada Test Site biota. This report summarizes the program's activities conducted by Bechtel Nevada during the Fiscal Year 2004 and the additional months of October, November, and December 2004, reflecting a change in the monitoring period to a calendar year rather than a fiscal year as reported in the past. This change in the monitoring period was made to better accommodate information requiredmore » for the Nevada Test Site Environmental Report, which reports on a calendar year rather than a fiscal year. Program activities included: (1) biological surveys at proposed construction sites, (2) desert tortoise compliance, (3) ecosystem mapping and data management, (4) sensitive species and unique habitat monitoring, (5) habitat restoration monitoring, and (6) biological monitoring at the Hazardous Materials Spill Center.« less

Advances in Behavioral Laboratory Methods that Inform Tobacco Regulatory Science: A TCORS Working Group Special Issue

PubMed Central

Wright, M. Jerry; Valentine, Gerald

2017-01-01

Objective The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) created unprecented enabling conditions for establishing national regulatory policy that reduces the burden of public health and societal problems associated with tobacco product use. The Center for Tobacco Products (CTP), created by the FDA to implement the TCA, developed a first-of-its-kind FDA/National Institutes of Health (NIH) collaborative program to fund Tobacco Centers of Regulatory Science (TCORS). Methods To assist the TCORS with addressing research priorites, working groups (WGs) comprised of FDA-CTP liasions and TCORS investigators were formed. Under the direction of the Center for Evaluation and Coordination of Trainin and Research (CECTR), the TCORS WGs seek to develop tangible work products in their respective areas of focus. Results The focus of the behavioral pharmacology WG evolved from publishing a narrow paper on behavioral methods in electronic cigarette research to a collection of papers on advances in behavioral laboratory methods that may inform tobacco regulatory science. Conclusion This Special Issue contains articles that address all of the CTP research priorities and demonstrates how advances in behavioral laboratory methods made by TCORS investigators can inform FDA efforst to regulate tobacco products. PMID:29152546

76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-24

...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment or prevention of neglected tropical diseases (NTDs), including clinical trial designs and internal review standards to support approval of drugs.

Fault detection and accommodation testing on an F100 engine in an F-15 airplane. [digital engine control system

NASA Technical Reports Server (NTRS)

Myers, L. P.; Baer-Riedhart, J. L.; Maxwell, M. D.

1985-01-01

The fault detection and accommodation (FDA) methods that can be used for digital engine control systems are presently subjected to a flight test program in the case of the F-15 fighter's F100 engine electronic controls, inducing selected faults and then evaluating the resulting digital engine control responses. In general, flight test results were found to compare well with both ground tests and predictions. It is noted that the inducement of dual-pressure failures was not feasible, since FDA logic was not designed to accommodate them.

32 CFR 56.10 - Ensuring compliance with this part in programs and activities conducted by the Department of...

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 1 2012-07-01 2012-07-01 false Ensuring compliance with this part in programs and activities conducted by the Department of Defense. 56.10 Section 56.10 National Defense Department... THE BASIS OF HANDICAP IN PROGRAMS AND ACTIVITIES ASSISTED OR CONDUCTED BY THE DEPARTMENT OF DEFENSE...

32 CFR 56.10 - Ensuring compliance with this part in programs and activities conducted by the Department of...

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 1 2014-07-01 2014-07-01 false Ensuring compliance with this part in programs and activities conducted by the Department of Defense. 56.10 Section 56.10 National Defense Department... THE BASIS OF HANDICAP IN PROGRAMS AND ACTIVITIES ASSISTED OR CONDUCTED BY THE DEPARTMENT OF DEFENSE...

32 CFR 56.10 - Ensuring compliance with this part in programs and activities conducted by the Department of...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 1 2010-07-01 2010-07-01 false Ensuring compliance with this part in programs and activities conducted by the Department of Defense. 56.10 Section 56.10 National Defense Department... THE BASIS OF HANDICAP IN PROGRAMS AND ACTIVITIES ASSISTED OR CONDUCTED BY THE DEPARTMENT OF DEFENSE...

32 CFR 56.10 - Ensuring compliance with this part in programs and activities conducted by the Department of...

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 1 2013-07-01 2013-07-01 false Ensuring compliance with this part in programs and activities conducted by the Department of Defense. 56.10 Section 56.10 National Defense Department... THE BASIS OF HANDICAP IN PROGRAMS AND ACTIVITIES ASSISTED OR CONDUCTED BY THE DEPARTMENT OF DEFENSE...

32 CFR 56.10 - Ensuring compliance with this part in programs and activities conducted by the Department of...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 1 2011-07-01 2011-07-01 false Ensuring compliance with this part in programs and activities conducted by the Department of Defense. 56.10 Section 56.10 National Defense Department... THE BASIS OF HANDICAP IN PROGRAMS AND ACTIVITIES ASSISTED OR CONDUCTED BY THE DEPARTMENT OF DEFENSE...

Economic return of clinical trials performed under the pediatric exclusivity program.

PubMed

Li, Jennifer S; Eisenstein, Eric L; Grabowski, Henry G; Reid, Elizabeth D; Mangum, Barry; Schulman, Kevin A; Goldsmith, John V; Murphy, M Dianne; Califf, Robert M; Benjamin, Daniel K

2007-02-07

In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been praised for creating incentives for studies in children and has been criticized as a "windfall" to the innovator drug industry. This critique has been a substantial part of congressional debate on the program, which is due to expire in 2007. To quantify the economic return to industry for completing pediatric exclusivity trials. A cohort study of programs conducted for pediatric exclusivity. Nine drugs that were granted pediatric exclusivity were selected. From the final study reports submitted to the FDA (2002-2004), key elements of the clinical trial design and study operations were obtained, and the cost of performing each study was estimated and converted into estimates of after-tax cash outflows. Three-year market sales were obtained and converted into estimates of after-tax cash inflows based on 6 months of additional market protection. Net economic return (cash inflows minus outflows) and net return-to-costs ratio (net economic return divided by cash outflows) for each product were then calculated. Net economic return and net return-to-cost ratio. The indications studied reflect a broad representation of the program: asthma, tumors, attention-deficit/hyperactivity disorder, hypertension, depression/generalized anxiety disorder, diabetes mellitus, gastroesophageal reflux, bacterial infection, and bone mineralization. The distribution of net economic return for 6 months of exclusivity varied substantially among products (net economic return ranged from -$8.9 million to $507.9 million and net return-to-cost ratio ranged from -0.68 to 73.63). The economic return for pediatric exclusivity is variable. As an incentive to complete much-needed clinical trials in children, pediatric exclusivity can generate lucrative returns or produce more modest returns on investment.