24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

Code of Federal Regulations, 2014 CFR

2014-04-01

... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

Code of Federal Regulations, 2010 CFR

2010-04-01

... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

77 FR 50514 - Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-21

...] Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the... Administration (FDA) is announcing the following public workshop entitled ``Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the Total Product Life Cycle.'' The topics...

30 CFR 550.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 2 2013-07-01 2013-07-01 false Do I have to conduct post-approval monitoring... INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information... monitoring? After approving your EP, DPP, or DOCD, the Regional Supervisor may direct you to conduct...

30 CFR 550.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 2 2014-07-01 2014-07-01 false Do I have to conduct post-approval monitoring... INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information... monitoring? After approving your EP, DPP, or DOCD, the Regional Supervisor may direct you to conduct...

30 CFR 550.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 2 2012-07-01 2012-07-01 false Do I have to conduct post-approval monitoring... INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information... monitoring? After approving your EP, DPP, or DOCD, the Regional Supervisor may direct you to conduct...

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE ECONOMIC ADJUSTMENT ASSISTANCE INVESTMENTS General § 307.6 Economic...

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE ECONOMIC ADJUSTMENT ASSISTANCE INVESTMENTS General § 307.6 Economic...

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE ECONOMIC ADJUSTMENT ASSISTANCE INVESTMENTS General § 307.6 Economic...

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE ECONOMIC ADJUSTMENT ASSISTANCE INVESTMENTS General § 307.6 Economic...

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE ECONOMIC ADJUSTMENT ASSISTANCE INVESTMENTS General § 307.6 Economic...

Post-approval Studies for Rare Disease Treatments and Orphan Drugs.

PubMed

Maier, William C; Christensen, Ronald A; Anderson, Patricia

2017-01-01

Drug development involves a multi-stage process of drug discovery, animal studies and human clinical trials to assess the safety and efficacy of new medications. Rare disease drug development involves a much smaller number of affected patients, a predominance of pediatric patients and more complicated disease presentation. Post-approval studies are designed to address several limitations associated with the rare disease clinical trials.National and international regulatory agencies in the US and Europe have adopted similar approaches to requirements post-approval data for rare diseases and orphan drug indications. The US FDA published guidance in 2011 and the European Medicines Agency in 2015.Post-approval studies for rare diseases include observational studies, pragmatic trials and randomized controlled studies. Observational studies include both original data collection studies and the use of secondary data (retrospective studies). Original data collection can address limitations of retrospective studies resulting from incomplete information in secondary data sources. Disease registries focus on detail about a broad range of patients with a rare disease while product-related registries focus on specific health care outcomes associated with a single product and may incorporate a comparator of an alternative therapy or therapies.Rare disease patients can be difficult to find and enroll in a registry using conventional physician based driven recruitment. The study process also needs to recognize changes in the patient's disease and lifestyle and adapt both the study design and methods over time. Many rare diseases have strong patient advocacy groups that can in aid the design and execution of rare disease registries.

Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

PubMed

Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

2018-06-01

Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

30 CFR 250.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 2 2012-07-01 2012-07-01 false Do I have to conduct post-approval monitoring... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and... monitoring? The Regional Supervisor may direct you to conduct monitoring programs. You must retain copies of...

30 CFR 250.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 2 2013-07-01 2013-07-01 false Do I have to conduct post-approval monitoring... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and... monitoring? The Regional Supervisor may direct you to conduct monitoring programs. You must retain copies of...

30 CFR 250.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 2 2014-07-01 2014-07-01 false Do I have to conduct post-approval monitoring... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and... monitoring? The Regional Supervisor may direct you to conduct monitoring programs. You must retain copies of...

Partner approval and intention to use contraception among Zanzibari women presenting for post-abortion care.

PubMed

Esber, Allahna; Foraker, Randi E; Hemed, Maryam; Norris, Alison

2014-07-01

We examined the effect of partner approval of contraception on intention to use contraception among women obtaining post-abortion care in Zanzibar. Our data source was a 2010 survey of 193 women obtaining post-abortion care at a large public hospital in Zanzibar. We used multivariable logistic regression analysis to assess associations between partner approval and intention to use contraception. Overall, 23% of participants had used a contraceptive method in the past, and 66% reported intending to use contraception in the future. We found that partner approval of contraception and ever having used contraception in the past were each associated with intending to use contraception in the future. In the multivariable model, adjusting for past contraception use, partner approval of contraception was associated with 20 times the odds of intending to use contraception (odds ratio, 20.25; 95% confidence interval, 8.45-48.56). We found a strong association between partner approval and intention to use contraception. Efforts to support contraceptive use must include both male and female partners. Public health and educational efforts to increase contraceptive use must include men and be targeted to both male and female partners. Given that male partners are often not present when women obtain health care, creative efforts will be required to meet men in community settings. Copyright © 2014 Elsevier Inc. All rights reserved.

Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

PubMed

Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

2018-01-15

Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

A Good Year: FDA Approved Nine New Cancer Drugs in 2014

Cancer.gov

In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

Real-world evidence analysis of palbociclib prescribing patterns for patients with advanced/metastatic breast cancer treated in community oncology practice in the USA one year post approval.

PubMed

Kish, J K; Ward, M A; Garofalo, D; Ahmed, H V; McRoy, L; Laney, J; Zanotti, G; Braverman, J; Yu, H; Feinberg, B A

2018-05-02

Rapidly evolving understanding of cancer biology has presented novel opportunities to translate that understanding into clinically relevant therapy. Palbociclib, a novel, first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor was approved in the USA in February 2015 for the treatment of advanced/metastatic breast cancer. We examined real-world evidence in the first year post approval to understand the clinical and demographic characteristics of patients treated with palbociclib in community oncology practices and the dosing, treatment, and complete blood count (CBC) monitoring patterns. This was a retrospective observational study of structured data from a US electronic medical record (EMR) database. Female patients receiving palbociclib after 31 January 2015 were followed through 31 March 2016. Our methodological rules were constructed to aggregate drugs received according to the order in which they are given, i.e., identify the line of therapy as first, second, or third line, etc., using treatment order and course description fields from the EMR. There were 763 patients initiating palbociclib who met the selection criteria. Of those, 612 (80.2%) received palbociclib concomitantly with letrozole. Mean follow up was 6.4 months and mean age at palbociclib initiation was 64 years. Of patients with a known starting dose (n = 417), 79.9% started on palbociclib 125 mg. Dose reductions were observed in 20.1% of patients. Percentages of patients according to line of therapy at initiation of palbociclib were first-line, 39.5%; second-line, 15.7%; third-line, 13.1%; and fourth-line therapy or later, 31.7%. On average, two CBC tests were conducted during the first cycle of palbociclib treatment. Overall, 74.6% of patients had a neutropenic event during follow up including 47.3% and 8.0% of patients with a grade 3 or 4 occurrence, respectively. Real-world palbociclib use one year post US approval demonstrates a more heterogeneous patient population than that

Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles

PubMed Central

Lee, Bruce Y.; Burke, Donald S.

2012-01-01

As history has demonstrated, post-approval obstacles can impede a vaccine’s use and potentially lead to its withdrawal. Addressing these potential obstacles when changes in a vaccine’s technology can still be easily made may improve a vaccine’s chances of success. Augmented vaccine target product profiles (TPPs) can help vaccine scientists better understand and anticipate these obstacles and galvanize conversations among various vaccine stakeholders (e.g., scientists, marketers, business development managers, policy makers, public health officials, health care workers, third party payors, etc.) earlier in a vaccine’s development. PMID:19782109

Post-Closure Inspection Report for the Tonopah Test Range, Nevada, for Calendar Year 2014

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

Silvas, A. J.; Lantow, Tiffany A.

This report provides the results of the annual post-closure inspections conducted at the closed Corrective Action Units (CAUs) located on the Tonopah Test Range (TTR), Nevada. This report covers calendar year 2014 and includes inspection and repair activities completed at the following CAUs; CAU 400: Bomblet Pit and Five Points Landfill (TTR); CAU 407: Roller Coaster RadSafe Area (TTR); CAU 424: Area 3 Landfill Complexes (TTR); CAU 453: Area 9 UXO Landfill (TTR); and CAU 487: Thunderwell Site (TTR) Inspections were conducted according to the post-closure plans in the approved Closure Reports and subsequent correspondence with the Nevada Division ofmore » Environmental Protection. The post-closure inspection plans and subsequent correspondence modifying the requirements for each CAU are included in Appendix B. The inspection checklists are included in Appendix C. Photographs taken during inspections are included in Appendix D. The annual post-closure inspections were conducted on May 28, 2014. Maintenance was required at CAU 407. Animal burrows were backfilled and erosion repairs were performed. Vegetation monitoring was performed at CAU 407 in June 2014. The vegetation monitoring report is included in Appendix E.« less

30 CFR 7.91 - Post-approval product audit.

Code of Federal Regulations, 2014 CFR

2014-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

30 CFR 7.91 - Post-approval product audit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

30 CFR 7.91 - Post-approval product audit.

Code of Federal Regulations, 2010 CFR

2010-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

30 CFR 7.91 - Post-approval product audit.

Code of Federal Regulations, 2012 CFR

2012-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

30 CFR 7.91 - Post-approval product audit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

PubMed Central

Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

2015-01-01

Aims Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). Methods We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA’s 210 day regulatory deadline. Results Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276–406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Conclusions Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. PMID:25808713

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

PubMed

Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

2015-10-01

Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline. Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. © 2015 The British Pharmacological Society.

What "likes" have got to do with it: Exposure to peers' alcohol-related posts and perceptions of injunctive drinking norms.

PubMed

Boyle, Sarah C; Smith, Daniel J; Earle, Andrew M; LaBrie, Joseph W

2018-01-01

Examine 1) whether observed social reinforcements (i.e., "likes") received by peers' alcohol-related social media posts are related to first-year college students' perceptions of peer approval for risky drinking behaviors; and 2) whether associations are moderated by students' alcohol use status. First-year university students (N = 296) completed an online survey in September, 2014. Participants reported their own alcohol use, friends' alcohol use, perceptions of the typical student's approval for risky drinking, and ranked 10 types of social media posts in terms of the relative numbers of "likes" received when posted by peers. Observed social reinforcement (i.e., "likes") for peers' alcohol-related posts predicted perceptions of peer approval for risky drinking behaviors among non-drinking students, but not drinking students. For first-year college students who have not yet initiated drinking, observing peers' alcohol-related posts to receive abundant "likes" may increase perceptions of peer approval for risky drinking.

Approved Antiviral Drugs over the Past 50 Years

PubMed Central

2016-01-01

SUMMARY Since the first antiviral drug, idoxuridine, was approved in 1963, 90 antiviral drugs categorized into 13 functional groups have been formally approved for the treatment of the following 9 human infectious diseases: (i) HIV infections (protease inhibitors, integrase inhibitors, entry inhibitors, nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, and acyclic nucleoside phosphonate analogues), (ii) hepatitis B virus (HBV) infections (lamivudine, interferons, nucleoside analogues, and acyclic nucleoside phosphonate analogues), (iii) hepatitis C virus (HCV) infections (ribavirin, interferons, NS3/4A protease inhibitors, NS5A inhibitors, and NS5B polymerase inhibitors), (iv) herpesvirus infections (5-substituted 2′-deoxyuridine analogues, entry inhibitors, nucleoside analogues, pyrophosphate analogues, and acyclic guanosine analogues), (v) influenza virus infections (ribavirin, matrix 2 protein inhibitors, RNA polymerase inhibitors, and neuraminidase inhibitors), (vi) human cytomegalovirus infections (acyclic guanosine analogues, acyclic nucleoside phosphonate analogues, pyrophosphate analogues, and oligonucleotides), (vii) varicella-zoster virus infections (acyclic guanosine analogues, nucleoside analogues, 5-substituted 2′-deoxyuridine analogues, and antibodies), (viii) respiratory syncytial virus infections (ribavirin and antibodies), and (ix) external anogenital warts caused by human papillomavirus infections (imiquimod, sinecatechins, and podofilox). Here, we present for the first time a comprehensive overview of antiviral drugs approved over the past 50 years, shedding light on the development of effective antiviral treatments against current and emerging infectious diseases worldwide. PMID:27281742

FDA Approvals - Cancer Currents Blog

Cancer.gov

Blog posts on cancer drugs and devices approved by the Food and Drug Administration—including summaries of the evidence to support the approvals and what they mean for patients—from NCI Cancer Currents.

Procedural trends, outcomes, and readmission rates pre-and post-FDA approval for MitraClip from the National Readmission Database (2013-14).

PubMed

Panaich, Sidakpal S; Arora, Shilpkumar; Badheka, Apurva; Kumar, Varun; Maor, Elad; Raphael, Claire; Deshmukh, Abhishek; Reeder, Guy; Eleid, Mackram; Rihal, Charanjit S

2018-05-01

There are sparse clinical data on the procedural trends, outcomes and readmission rates following FDA approval and expansion of Transcatheter mitral valve repair/MitraClip ® . Whether a complex new technology can be disseminated safely and quickly is controversial. The study cohort was derived from the National Readmission Data (NRD) 2013-14. MitraClip ® was identified using appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. The primary outcome was a composite of in-hospital mortality + procedural complications. Secondary outcome included 30-day readmissions. Hierarchical two level logistic models were used to evaluate study outcomes. Our analysis included 2003 MitraClip ® procedures. Overall in-hospital mortality was 3.9%. As expected, there was a significant increase in procedural volume post-FDA approval. Importantly, a corresponding downward trend in mortality and procedural complications was observed. Significant predictors of in-hospital mortality and procedural complications included the use of vasopressors (P <0.001) and hemodynamic support (P < 0.001). Higher hospital volume (≥10 MitraClips/year) was associated with lower in-hospital mortality and complications (P = 0.02). There were 304 (15.1%) 30-day readmissions, with heart failure being the most common cause of readmission. Elective procedures had lower in-hospital mortality (P < 0.001) and lower readmission rates (P = 0.011) compared with nonelective procedures. A significant increase in MitraClip ® procedural volumes occurred post-FDA approval. Overall morbidity and mortality were low and trended downwards. Hospital procedure volume ≥10 cases were associated with lower mortality and overall complication rates. These data suggest a successful roll out of a very complex novel structural heart procedure. © 2017 Wiley Periodicals, Inc.

Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Qualification & Approval Bodies

ERIC Educational Resources Information Center

Wheelahan, Leesa; Buchanan, John; Yu, Serena

2015-01-01

This summary pulls together the relevant key findings for qualification and approval bodies from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education…

77 FR 60085 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Inventory for the... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the... Quality Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5 emissions inventory...

77 FR 60094 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Inventory for the... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the... Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5 emissions inventory for the...

77 FR 60087 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Inventory for the... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the... National Ambient Air Quality Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5...

29 CFR 37.64 - What procedures must the Director follow when CRC has completed a post-approval compliance review?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true What procedures must the Director follow when CRC has completed a post-approval compliance review? 37.64 Section 37.64 Labor Office of the Secretary of Labor... (WIA) Compliance Procedures § 37.64 What procedures must the Director follow when CRC has completed a...

12 CFR 336.12 - One-year post-employment restriction.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false One-year post-employment restriction. 336.12 Section 336.12 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION REGULATIONS AND STATEMENTS OF....12 One-year post-employment restriction. (a) Prohibition. An officer or employee of the FDIC who...

[Ten years experience with the first approved biosimilar recombinant human growth hormone drug in normal clinical practice].

PubMed

López-Siguero, Juan Pedro; Palla García, Margarida; Martínez Busto, Elena; Rebollo, Francisco José; Pombo, Manuel

2018-04-01

Recombinant human growth hormone (rhGH) is the first biosimilar drug approved by the European Medicines Agency in 2006, using the biosimilar registration process. It was authorised for the treatment of growth hormone deficiency, and growth disorders associated with Turner's syndrome, chronic renal failure, Prader-Willi syndrome, and growth disorders in children/adolescents born small for gestational age, and replacement therapy in adults with pronounced growth hormone deficiency. This review is focused on the scientific evidence published about this drug in the last ten years, including the clinical trials on which the approval of the regulatory authority is based, and the most relevant studies evaluating the clinical impact of the drug in clinical practice. The equivalence between biosimilar and original product has been confirmed in the clinical trials published by Romer et al. and López-Siguero et al. Furthermore, studies carried out in real-life conditions confirm its long-term efficacy and safety, as well as the absence of clinical impact by switching treatment from the original to the biosimilar product. The number of patients receiving this medication has continuously increased since its approval. Its equivalence with the original product has been verified. Preliminary data from the post-authorisation PATRO study confirm the efficacy and safety of the biosimilar product in comparison with data from clinical trials. However, final results must be evaluated at the end of the study, which will provide additional information about the long-term efficacy and safety of the biosimilar drug. Copyright © 2016 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

The Effect of Post Traumatic Stress Disorder on Military Leadership: An Historical Perspective

DTIC Science & Technology

2011-05-19

Post Traumatic Stress Disorder ( PTSD ) on military leadership. For over twenty years, the United States Army has used the Be...Introduction Multiple deployment cycles to Iraq and Afghanistan combat zones and the increase in Post - Traumatic Stress Disorder ( PTSD ) have resulted...Approved for Public Release; Distribution is Unlimited The Effect of Post Traumatic Stress Disorder on Military Leadership: An

Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data.

PubMed

Strech, Daniel; Littmann, Jasper

2012-07-02

For the protection of commercial interests, licensing bodies such as the EMA and health technology assessment institutions such as NICE restrict full access to unpublished evidence. Their respective policies on data transparency, however, lack a systematic account of (1) what kinds of commercial interests remain relevant after market approval has been granted, (2) what the specific types of public interest are that may override these commercial interests post approval, and, most importantly, (3) what criteria guide the trade-off between public interest and legitimate measures for the protection of commercial interest. Comparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.

Immunotherapy Combination Approved for Advanced Kidney Cancer

Cancer.gov

FDA has approved the combination of the immunotherapy drugs nivolumab (Opdivo) and ipilimumab (Yervoy) as an initial treatment for some patients with advanced kidney cancer. The approval is expected to immediately affect patient care, as this Cancer Currents post explains.

Tisagenlecleucel (Kymriah) Approved to Treat Some Lymphomas

Cancer.gov

FDA has approved the CAR T-cell therapy tisagenlecleucel for adults with diffuse large B-cell lymphoma that is relapsed or refractory. Learn more about this new approval and how it may affect patients in this NCI Cancer Currents blog post.

Post-Closure Inspection Report for the Tonopah Test Range, Nevada, for Calendar Year 2013

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

Silvas, A. J.

2014-03-03

This report provides the results of the annual post-closure inspections conducted at the closed Corrective Action Units (CAUs) located on the Tonopah Test Range (TTR), Nevada. This report covers calendar year 2013 and includes inspection and repair activities completed at the following CAUs: • CAU 400: Bomblet Pit and Five Points Landfill (TTR) • CAU 407: Roller Coaster RadSafe Area (TTR) • CAU 424: Area 3 Landfill Complexes (TTR) • CAU 453: Area 9 UXO Landfill (TTR) • CAU 487: Thunderwell Site (TTR) Inspections were conducted according to the post-closure plans in the approved Closure Reports and subsequent correspondence withmore » the Nevada Division of Environmental Protection. The post-closure inspection plans and subsequent correspondence modifying the requirements for each CAU are included in Appendix B. The inspection checklists are included in Appendix C. Field notes are included in Appendix D. Photographs taken during inspections are included in Appendix E. The annual post-closure inspections were conducted on May 14, 2013. Maintenance was performed at CAU 400, CAU 424, and CAU 453. At CAU 400, animal burrows were backfilled. At CAU 424, erosion repairs were completed at Landfill Cell A3-3, subsidence was repaired at Landfill Cell A3-4, and additional lava rock was placed in high-traffic areas to mark the locations of the surface grade monuments at Landfill Cell A3-3 and Landfill Cell A3-8. At CAU 453, two areas of subsidence were repaired and animal burrows were backfilled. Vegetation monitoring was performed at the CAU 400 Five Points Landfill and CAU 407 in June 2013. The vegetation monitoring report is included in Appendix F.« less

Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel.

PubMed

Stevens, W Grant; Harrington, Jennifer; Alizadeh, Kaveh; Broadway, David; Zeidler, Kamakshi; Godinez, Tess B

2015-05-01

On March 9, 2012, the Food and Drug Administration (FDA) approved Sientra's premarket approval application for its portfolio of silicone gel breast implants based on their review of Sientra's 3-year study data from the largest pivotal silicone gel breast implant study to date. This included the first approval of shaped breast implants in the United States. The authors provide an update to the 8-year safety and effectiveness of the Sientra High-Strength silicone gel breast implants. The Sientra Core study is an ongoing 10 year open-label, prospective, multi-center clinical study, which includes 1788 patients implanted with 3506 Sientra implants across four indications (Primary Augmentation, Revision Augmentation, Primary Reconstruction, and Revision Reconstruction). For the safety analysis, the incidence of post-operative complications, including all breast implant-related adverse effects (eg, infection, asymmetry), was estimated based on Kaplan-Meier risk rates. The effectiveness analyses include surgeon and patient satisfaction and changes in bra/cup size. Through 8 years, the overall risk of rupture was 4.6%, the risk of capsular contracture was 11.8% (rates were lower when using True Texture™), and the risk of reoperation was 28.3%. Out of the 580 reoperations in 456 patients, over half of all reoperations were due to cosmetic reasons (n = 299). The most common reasons for reoperation were capsular contracture (19.0%), style and/or size change (18.4%), and asymmetry (8.8%). Patient satisfaction remains high through 8 years, with 87% indicating that their breast implants make them feel more feminine than prior to enrollment. Safety data from the FDA Core study continues to support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped implants through 8 years. 3 Therapeutic. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Predictors of subjective health status 10 years post-PCI.

PubMed

van den Berge, Jan C; Dulfer, Karolijn; Utens, Elisabeth M W J; Hartman, Eline M J; Daemen, Joost; van Geuns, Robert J; van Domburg, Ron T

2016-06-01

Subjective health status is an increasingly important parameter to assess the effect of percutaneous coronary intervention (PCI) in clinical practice. Aim of this study was to determine medical and psychosocial predictors of poor subjective health status over a 10 years' post-PCI period. We included a series of consecutive PCI patients (n = 573) as part of the RESEARCH registry, a Dutch single-center retrospective cohort study. These patients completed the 36-item Short-Form Health Survey (SF-36) at baseline and 10 years post-PCI. We found 6 predictors of poor subjective health status 10 years post-PCI: SF-36 at baseline, age, previous PCI, obesity, acute myocardial infarction as indication for PCI, and diabetes mellitus (arranged from most to least numbers of sub domains). SF-36 scores at baseline, age, and previous PCI were significant predictors of subjective health status 10 years post-PCI. Specifically, the SF-36 score at baseline was an important predictor. Thus assessment of subjective health status at baseline is useful as an indicator to predict long-term subjective health status. Subjective health status becomes better by optimal medical treatment, cardiac rehabilitation and psychosocial support. This is the first study determining predictors of subjective health status 10 years post-PCI.

Abemaciclib gets new approval for breast cancer

Cancer.gov

DA has approved the CDK4/6 inhibitor abemaciclib (Verzenio) as a first-line treatment in some women with advanced or metastatic breast cancer. Under the approval, it must be used in combination with an aromatase inhibitor, as this Cancer Currents blog post explains.

77 FR 24399 - Approval and Promulgation of Implementation Plans; Georgia; Atlanta; Ozone 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-24

... Promulgation of Implementation Plans; Georgia; Atlanta; Ozone 2002 Base Year Emissions Inventory AGENCY... approve the ozone 2002 base year emissions inventory, portion of the state implementation plan (SIP... Atlanta, Georgia (hereafter referred to as ``the Atlanta Area'' or ``Area''), ozone attainment...

Physical inactivity post-stroke: a 3-year longitudinal study.

PubMed

Kunkel, Dorit; Fitton, Carolyn; Burnett, Malcolm; Ashburn, Ann

2015-01-01

To explore change in activity levels post-stroke. We measured activity levels using the activPAL™ in hospital and at 1, 2 and 3 years' post-stroke onset. Of the 74 participants (mean age 76 (SD 11), 39 men), 61 were assessed in hospital: 94% of time was spent in sitting/lying, 4% standing and 2% walking. Activity levels improved over time (complete cases n = 15); time spent sitting/lying decreased (p = 0.001); time spent standing, walking and number of steps increased (p = 0.001, p = 0.028 and p = 0.03, respectively). At year 3, 18% of time was spent in standing and 9% walking. Time spent upright correlated significantly with Barthel (r = 0.69 on admission, r = 0.68 on discharge, both p < 0.01) and functional ambulation category scores (r = 0.55 on admission, 0.63 on discharge, both p < 0.05); correlations remained significant at all assessment points. Depression (in hospital), left hemisphere infarction (Years 1-2), visual neglect (Year 2), poor mobility and balance (Years 1-3) correlated with poorer activity levels. People with stroke were inactive for the majority of time. Time spent upright improved significantly by 1 year post-stroke; improvements slowed down thereafter. Poor activity levels correlated with physical and psychological measures. Larger studies are indicated to identify predictors of activity levels. Implications for Rehabilitation Activity levels (measured using activPAL™ activity monitor), increased significantly by 1 year post-stroke but improvements slowed down at 2 and 3 years. People with stroke were inactive for the majority of their day in hospital and in the community. Poor activity levels correlated with physical and psychological measures. Larger studies are indicated to identify the most important predictors of activity levels.

Post-Closure Inspection Report for the Tonopah Test Range, Nevada, For Calendar Year 2011

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

NSTec Environmental Restoration

This report provides the results of the annual post-closure inspections conducted at the closed Corrective Action Units (CAUs) located on the Tonopah Test Range (TTR), Nevada. This report covers calendar year 2011 and includes inspection and repair activities completed at the following CAUs: (1) CAU 400: Bomblet Pit and Five Points Landfill (TTR); (2) CAU 407: Roller Coaster RadSafe Area (TTR); (3) CAU 424: Area 3 Landfill Complexes (TTR); (4) CAU 453: Area 9 UXO Landfill (TTR); and (5) CAU 487: Thunderwell Site (TTR) Inspections were conducted according to the post-closure plans in the approved Closure Reports. The post-closure inspectionmore » plan for each CAU is included in Appendix B. The inspection checklists are included in Appendix C, field notes are included in Appendix D, and photographs taken during inspections are included in Appendix E. The annual post-closure inspections were conducted May 3 and 4, 2011. Maintenance was performed at CAU 424, CAU 453, and CAU 487. At CAU 424, two surface grade monuments at Landfill Cell A3-3 could not be located during the inspection. The two monuments were located and marked with lava rock on July 13, 2011. At CAU 453, there was evidence of animal burrowing. Animal burrows were backfilled on July 13, 2011. At CAU 487, one use restriction warning sign was missing, and wording was faded on the remaining signs. A large animal burrow was also present. The signs were replaced, and the animal burrow was backfilled on July 12, 2011. As a best management practice, the use restriction warning signs at CAU 407 were replaced with standard Federal Facility Agreement and Consent Order signs on July 13, 2011. Vegetation monitoring was performed at the CAU 400 Five Points Landfill and CAU 407 in June 2011, and the vegetation monitoring report is included in Appendix F.« less

18 CFR 806.31 - Term of approvals.

Code of Federal Regulations, 2010 CFR

2010-04-01

... approval issued under this part shall be no longer than 15 years or the anticipated life of the project... AND APPROVAL OF PROJECTS Terms and Conditions of Approval § 806.31 Term of approvals. (a) Approvals... approval of a project shall expire three years from the date of such approval if the withdrawal, diversion...

77 FR 42686 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; the 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... Promulgation of Air Quality Implementation Plans; Maryland; the 2002 Base Year Inventory AGENCY: Environmental... matter (PM 2.5 ) 2002 base year emissions inventory portion of the Maryland State Implementation Plan... National Ambient Air Quality Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5...

The One-Year Attributable Cost of Post-Stroke Dysphagia

PubMed Central

Bonilha, Heather Shaw; Simpson, Annie N.; Ellis, Charles; Mauldin, Patrick; Martin-Harris, Bonnie; Simpson, Kit

2014-01-01

With the recent emphasis on evidence-based practice and healthcare reform, understanding the cost of dysphagia management has never been more important. It is helpful for clinicians to understand and objectively report the costs associated with dysphagia when they advocate for their services in this economy. Having carefully estimated cost of illness, inputs are needed for cost-effectiveness analyses that help support the value of treatments. This study sought to address this issue by examining the 1-year cost associated with a diagnosis of dysphagia post-stroke in South Carolina. Furthermore, this study investigated whether ethnicity and residence differences exist in the cost of dysphagia post-stroke. Data on 3,200 patients in the South Carolina Medicare database from 2004 who had ICD-9 codes for ischemic stroke, 434 and 436, were retrospectively included in this study. Differences between persons with and without dysphagia post-stroke were compared with respect to age, gender, ethnicity, mortality, length of stay, comorbidity, rurality, discharge disposition, and cost to Medicare. Univariate analyses and a gamma-distributed generalized linear multivariable model with a log link function were completed. We found that the 1-year cost to Medicare for persons with dysphagia post ischemic stroke was $4,510 higher than that for persons without dysphagia post ischemic stroke when controlling for age, comorbidities, ethnicity, and proportion of time alive. Univariate analysis revealed that rurality, ethnicity, and gender were not statistically significantly different in comparisons of individuals with or without dysphagia post-stroke. Post-stroke dysphagia significantly increases post-stroke medical expenses. Understanding the expenditures associated with post-stroke dysphagia is helpful for optimal allocation and use of resources. Such information is needed to conduct cost-effectiveness studies. PMID:24948438

The one-year attributable cost of post-stroke dysphagia.

PubMed

Bonilha, Heather Shaw; Simpson, Annie N; Ellis, Charles; Mauldin, Patrick; Martin-Harris, Bonnie; Simpson, Kit

2014-10-01

With the recent emphasis on evidence-based practice and healthcare reform, understanding the cost of dysphagia management has never been more important. It is helpful for clinicians to understand and objectively report the costs associated with dysphagia when they advocate for their services in this economy. Having carefully estimated cost of illness, inputs are needed for cost-effectiveness analyses that help support the value of treatments. This study sought to address this issue by examining the 1-year cost associated with a diagnosis of dysphagia post-stroke in South Carolina. Furthermore, this study investigated whether ethnicity and residence differences exist in the cost of dysphagia post-stroke. Data on 3,200 patients in the South Carolina Medicare database from 2004 who had ICD-9 codes for ischemic stroke, 434 and 436, were retrospectively included in this study. Differences between persons with and without dysphagia post-stroke were compared with respect to age, gender, ethnicity, mortality, length of stay, comorbidity, rurality, discharge disposition, and cost to Medicare. Univariate analyses and a gamma-distributed generalized linear multivariable model with a log link function were completed. We found that the 1-year cost to Medicare for persons with dysphagia post ischemic stroke was $4,510 higher than that for persons without dysphagia post ischemic stroke when controlling for age, comorbidities, ethnicity, and proportion of time alive. Univariate analysis revealed that rurality, ethnicity, and gender were not statistically significantly different in comparisons of individuals with or without dysphagia post-stroke. Post-stroke dysphagia significantly increases post-stroke medical expenses. Understanding the expenditures associated with post-stroke dysphagia is helpful for optimal allocation and use of resources. Such information is needed to conduct cost-effectiveness studies.

Dabrafenib Plus Trametinib Approved for Melanoma, Thyroid Cancer

Cancer.gov

FDA recently approved the combination of dabrafenib (Taflinar) and trametinib (Mekinist) to treat some patients with melanoma and anaplastic thyroid cancer whose tumors have a mutation in the BRAF gene. As this Cancer Currents blog post explains, this is the first treatment approved specifically for anaplastic thyroid

Post-Closure Inspection Report for the Tonopah Test Range, Nevada. For Calendar Year 2015, Revision 0

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

Matthews, Patrick; Petrello, Jaclyn

This report provides the results of the annual post-closure inspections conducted at the closed corrective action units (CAUs) located on the Tonopah Test Range (TTR), Nevada. This report covers calendar year 2015 and includes inspection and repair activities completed at the following CAUs; CAU 400: Bomblet Pit and Five Points Landfill (TTR); CAU 407: Roller Coaster RadSafe Area (TTR); CAU 424: Area 3 Landfill Complexes (TTR); CAU 453: Area 9 UXO Landfill (TTR); and CAU 487: Thunderwell Site (TTR) Inspections were conducted according to the post-closure plans in the approved closure reports and subsequent correspondence with the Nevada Division ofmore » Environmental Protection. The post-closure inspection plans and subsequent correspondence modifying the requirements for each CAU are included in Appendix B. The inspection checklists are included in Appendix C. Field notes are included in Appendix D. The annual post-closure inspections were conducted on May 12, 2015. Maintenance was required at CAU 453. Cracking along the north trench was repaired. One monument is missing at CAU 424; it will be replaced in 2016. Postings at CAUs 407, 424, 453, and 487 contain contact information for TTR Security. It was noted that protocols may not be in place to ensure that the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO) is notified if access is needed at these sites. NNSA/NFO is working with the U.S. Air Force and Sandia to determine whether more appropriate contact information or new protocols are warranted for each CAU. Based on these inspections, there has not been a significant change in vegetation, and vegetation monitoring was not recommended at CAU 400 or CAU 407 in 2015.« less

Clinically feasible stratification of 1-year to 3-year post-myocardial infarction risk

PubMed Central

Muhlestein, Joseph B; Bhandary, Durgesh; Hoetzer, Greta L; Khan, Naeem D; Bair, Tami L; Lappé, Donald L

2018-01-01

Objective Post-myocardial infarction (MI) care is crucial to preventing recurrent major adverse cardiovascular events (MACE), but can be complicated to personalise. A tool is needed that effectively stratifies risk of cardiovascular (CV) events 1–3 years after MI but is also clinically usable. Methods Patients surviving ≥1 year after an index MI with ≥1 risk factor for recurrent MI (ie, age ≥65 years, prior MI, multivessel coronary disease, diabetes, glomerular filtration rate <60 mL/min/1.73 m2) were studied. Cox regression derived sex-specific Intermountain Major Adverse Cardiovascular Events (IMACE) risk scores for the composite of 1-year to 3-year MACE (CV death, MI or stroke). Derivation was performed in 70% of subjects (n=1342 women; 3047 men), with validation in the other 30% (n=576 women; 1290 men). Secondary validations were also performed. Results In women, predictors of CV events were glucose, creatinine, haemoglobin, platelet count, red cell distribution width (RDW), age and B-type natriuretic peptide (BNP); among men, they were potassium, glucose, blood urea nitrogen, haematocrit, white blood cell count, RDW, mean platelet volume, age and BNP. In the primary validation, in women, IMACE ranged from 0 to 11 (maximum possible: 12) and had HR=1.44 per +1 score (95% CI 1.29 to 1.61; P<0.001); men had IMACE range 0–14 (maximum: 16) and HR=1.29 per +1 score (95% CI 1.20 to 1.38; P<0.001). IMACE ≥5 in women (≥6 in men) showed strikingly higher MACE risk. Conclusions Sex-specific risk scores strongly stratified 1-year to 3-year post-MI MACE risk. IMACE is an inexpensive, dynamic, electronically delivered tool for evaluating and better managing post-MI patient care. PMID:29531761

29 CFR 1952.10 - Requirements for approval of State posters.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 9 2013-07-01 2013-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

29 CFR 1952.10 - Requirements for approval of State posters.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 9 2011-07-01 2011-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

29 CFR 1952.10 - Requirements for approval of State posters.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 9 2014-07-01 2014-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

29 CFR 1952.10 - Requirements for approval of State posters.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 9 2012-07-01 2012-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

29 CFR 1952.10 - Requirements for approval of State posters.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

38 CFR 21.9765 - Program of education approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21.9765 Program of education approval. VA may provide educational assistance for pursuit of a program of...

38 CFR 21.9765 - Program of education approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21.9765 Program of education approval. VA may provide educational assistance for pursuit of a program of...

38 CFR 21.9765 - Program of education approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21.9765 Program of education approval. VA may provide educational assistance for pursuit of a program of...

38 CFR 21.9765 - Program of education approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21.9765 Program of education approval. VA may provide educational assistance for pursuit of a program of...

38 CFR 21.9765 - Program of education approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21.9765 Program of education approval. VA may provide educational assistance for pursuit of a program of...

Evaluation of Nutritional Status Post Laparoscopic Sleeve Gastrectomy-5-Year Outcomes.

PubMed

Al-Mutawa, Aliaa; Al-Sabah, Salman; Anderson, Alfred Kojo; Al-Mutawa, Mohammad

2018-06-01

Obesity is considered a public health problem and has led to advancements in bariatric surgery. Laparoscopic sleeve gastrectomy (LSG) had become the most performed procedure worldwide; however, its consequences on nutritional status in the short and long term are of concern. A retrospective analysis of medical records and bariatric database of patients who underwent LSG from October 2008-September 2015 at Al-Amiri Hospital, Kuwait, was performed. Data regarding nutritional status along with demographic data were collected over a 5-year follow-up period. One thousand seven hundred ninety-three patients comprising of 74% females and 26% males were included. The greatest % total body weight loss (%TBWL) was at 18 months post-LSG (33%), corresponding to a % excess weight loss (%EWL) of 73.8%. With regard to nutritional status, vitamin B1 showed a significant drop at 3-5 years post-op in comparison to pre-op value, but stayed within the normal range throughout the study. Red blood cells count, hemoglobin, and hematocrit also showed a significant drop starting from 6 months post-op until the fifth year of follow-up. On the other hand, vitamins B6 and B12 showed a significant increase at 6 months post-op and decreased afterwards, but did not reach pre-op values. Vitamin D also showed a significant increase throughout the study period from deficient value at the pre-op time, but remained insufficient. Albumin, transferrin, folate, ferritin, iron, and vitamin B2 showed no significant changes at 5 years post-LSG compared to pre-op values. Little is known about the nutritional status and optimal nutritional care plan post-LSG, especially in the longer term. Nutritional deficiencies were prevalent prior and post-LSG. Some of the nutritional parameters improved and even reached the abnormal high level post-LSG. These observations highlight the importance of pre- and post-operative nutritional assessment and tailored supplementation to ensure optimal nutritional status.

77 FR 73313 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; The 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-10

... Promulgation of Air Quality Implementation Plans; Maryland; The 2002 Base Year Inventory for the Baltimore, MD... approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the State of... Department of the Environment (MDE), on June 6, 2008 for Baltimore, Maryland. The emissions inventory is part...

76 FR 6559 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations... Promulgation of Air Quality Implementation Plans; Pennsylvania; 2002 Base Year Emissions Inventory, Reasonable... revision. EPA is approving this SIP revision because it satisfies Clean Air Act (CAA) requirements for the...

77 FR 24440 - Approval and Promulgation of Implementation Plans; Georgia; Atlanta; Ozone 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-24

... Promulgation of Implementation Plans; Georgia; Atlanta; Ozone 2002 Base Year Emissions Inventory AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve the ozone... (hereafter referred to as ``the Atlanta Area'' or ``Area''), ozone attainment demonstration that was...

FDA Approves Apalutamide for Prostate Cancer

Cancer.gov

Apalutamide (Erleada) is a hormone therapy that counteracts resistance to androgen deprivation therapy. Learn more about the FDA approval of apalutamide for men with castration-resistant nonmetastatic prostate cancer in this Cancer Currents blog post.

How drugs are developed and approved by the FDA: current process and future directions.

PubMed

Ciociola, Arthur A; Cohen, Lawrence B; Kulkarni, Prasad

2014-05-01

This article provides an overview of FDA's regulatory processes for drug development and approval, and the estimated costs associated with the development of a drug, and also examines the issues and challenges facing the FDA in the near future. A literature search was performed using MEDLINE to summarize the current FDA drug approval processes and future directions. MEDLINE was further utilized to search for all cost analysis studies performed to evaluate the pharmaceutical industry R&D productivity and drug development cost estimates. While the drug approval process remains at high risk and spans over multiple years, the FDA drug review and approval process has improved, with the median approval time for new molecular drugs been reduced from 19 months to 10 months. The overall cost to development of a drug remains quite high and has been estimated to range from $868M to $1,241M USD. Several new laws have been enacted, including the FDA Safety and Innovation Act (FDASIA) of 2013, which is designed to improve the drug approval process and enhance access to new medicines. The FDA's improved processes for drug approval and post-market surveillance have achieved the goal of providing patients with timely access to effective drugs while minimizing the risk of drug-related harm. The FDA drug approval process is not without controversy, as a number of well-known gastroenterology drugs have been withdrawn from the US market over the past few years. With the approval of the new FDASIA law, the FDA will continue to improve their processes and, working together with the ACG through the FDA-Related Matters Committee, continue to develop safe and effective drugs for our patients.

77 FR 75933 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Emissions Inventory for the...: Proposed rule. SUMMARY: EPA is proposing to approve the 2002 base year emissions inventory portion of the... inventory is part of a SIP revision that was submitted to meet West Virginia's nonattainment requirements...

Recovery in treated aphasia in the first year post-stroke.

PubMed

Sarno, M T; Levita, E

1979-01-01

During a one year post-stroke period of observation, the recovery trend in treated aphasic patients was characterized by general progression in communication skill. The most notable improvement occurred on a measure of everyday function with changes worthy of note on tasks of auditory comprehension and spontaneous word production. In the first 6 months post-stroke, the greatest gain occurred in aphasic patients classified as Fluent, and the least gain in Global aphasics. On the auditory comprehension task, however, improvement was noted in all aphasics regardless of type. In contrast, during the latter half of the first year post-stroke, Fluent aphasics showed least and Global aphasics the greatest improvement. In spite of their progress, Global aphasic patients remained considerably more impaired than the other groups. That the Global aphasics remained so impaired was expected, but the extent and temporal characteristics of their progress in communicating was unexpected.

$627 Million Gulf Spill Restoration Plan Approved | NOAA Gulf Spill

Science.gov Websites

Publications Press Releases Story Archive Home $627 Million Gulf Spill Restoration Plan Approved $627 Million Gulf Spill Restoration Plan Approved Bird landing on water share Posted on October 3, 2014 | Assessment Gulf of Mexico early restoration projects since the oil spill. The restoration plan includes 44

[Usefulness of bifonazole for treatment of tinea pedis in the 20th year after approval].

PubMed

Mitsui, Hiroshi; Kanda, Naoko; Ohnishi, Takamitsu; Nakai, Kenji; Suzuki, Taku; Watanabe, Shinichi

2009-04-01

We studied the usefulness of Mycospor Cream 1% (hereinafter referred to as "bifonazole cream"), which was approved 20 years ago in Japan, with once-daily application in 16 patients with tinea pedis (plantar tinea pedis, n = 8; interdigital tinea pedis, n = 8). One of them discontinued after 2 weeks of study treatment due to aggravation of skin symptoms. This subject was excluded from assessment of mycological activity and skin-symptom improvement at 4 weeks after initiation of treatment, but included in overall clinical efficacy rating and usefulness rating as an "ineffective" and "useless" case. The mean (+/- SD) duration of study treatment among the 15 subjects (excluding the discontinued subject) was 26.5 +/- 2.3 days (range: 21 to 28 days). The mycological eradication rate at Week 4 was 100% (15/15 subjects). The scores on all skin symptoms (itching, redness, papules, blisters, pustules, maceration, and scaling) at Week 4 significantly improved from the respective baseline scores (p<0.05), and almost all skin symptoms disappeared. The skin-symptom improvement rate was 93% (14/15 subjects). The overall clinical efficacy rate, which was assessed based on mycological efficacy and skin-symptom improvement rating, was 81% (13/16 subjects). No adverse reaction was observed in any of the subjects. The usefulness rate, which was assessed based on overall clinical efficacy and safety rating, was 88% (14/16 subjects). In this study, we confirmed that the usefulness of bifonazole cream for the treatment of tinea pedis was consistent with the results of studies performed before approval and 10 years after approval. About 20 years have passed since its launch, but bifonazole cream still remains a useful antifungal drug for topical treatment of tinea pedis.

Embedding Evidence-based Practice Education into a Post-graduate Physiotherapy Program: Eight Years of pre-Post Course Evaluations.

PubMed

Perraton, L; Machotka, Z; Grimmer, K; Gibbs, C; Mahar, C; Kennedy, K

2017-04-01

Little has been published about the effectiveness of training postgraduate physiotherapy coursework students in research methods and evidence-based practice (EBP) theory. Graduate qualities in most universities include lifelong learning. Inclusion of EBP in post-graduate coursework students' training is one way for students to develop the knowledge and skills needed to implement current best evidence in their clinical practice after graduation, thereby facilitating lifelong learning. This paper reports on change in confidence and anxiety in knowledge of statistical terminology and concepts related to research design and EBP in eight consecutive years of post-graduate physiotherapy students at one Australian university. Pre-survey/post-survey instruments were administered to students in an intensive 3-week post-graduate course, which taught health research methods, biostatistics and EBP. This course was embedded into a post-graduate physiotherapy programme from 2007 to 2014. The organization and delivery of the course was based on best pedagogical evidence for effectively teaching adult physiotherapists. The course was first delivered each year in the programme, and no other course was delivered concurrently. There were significant improvements in confidence, significantly decreased anxiety and improvements in knowledge of statistical terminology and concepts related to research design and EBP, at course completion. Age, gender and country of origin were not confounders on learning outcomes, although there was a (non-significant) trend that years of practice negatively impacted on learning outcomes (p = 0.09). There was a greater improvement in confidence in statistical terminology than in concepts related to research design and EBP. An intensive teaching programme in health research methods and biostatistics and EBP, based on best practice adult physiotherapy learning principles, is effective immediately post-course, in decreasing anxiety and increasing

Survival of two post systems--five-year results of a randomized clinical trial.

PubMed

Schmitter, Marc; Hamadi, Khaled; Rammelsberg, Peter

2011-01-01

To assess the survival rate of two different post systems after 5 years of service with a prospective randomized controlled trial. One hundred patients in need of a post were studied. Half of the patients received long glass fiber-reinforced posts, while the other half received long metal screw posts. The posts were assigned randomly. After at least 5 years (mean, 61.37 months), follow-ups were established. When a complication occurred prior to this recall, the type and time of the complication was documented. Statistical analysis was performed using the log-rank test and Kaplan-Meier analysis. Additionally, a Cox regression was performed to analyze risk factors. The survival rate of fiber-reinforced posts was 71.8%. In the metal screw post group, the survival rate was significantly lower, 50.0% (log-rank test, P = .026). Metal posts resulted more often in more unfavorable complications (eg, root fractures); consequently, more teeth (n = 17) had to be extracted. The Cox regression identified the following risk factors: position of the tooth (anterior vs posterior teeth), degree of coronal tooth destruction, and the post system (fiber-reinforced post vs metal screw post). Fiber-reinforced restorations loosened in several patients; in some of these cases (n = 6), patients did not notice this, leading to the extraction of teeth. Long metal screw posts should be used with great care in endodontically treated teeth. Besides the selection of the post system, other factors influence the survival of the restoration.

Remote sensing for prediction of 1-year post-fire ecosystem condition

Treesearch

Leigh B. Lentile; Alistair M. S. Smith; Andrew T. Hudak; Penelope Morgan; Michael J. Bobbitt; Sarah A. Lewis; Peter R. Robichaud

2009-01-01

Appropriate use of satellite data in predicting >1 year post-fire effects requires remote measurement of surface properties that can be mechanistically related to ground measures of post-fire condition. The present study of burned ponderosa pine (Pinus ponderosa) forests in the Black Hills of South Dakota evaluates whether immediate fractional cover estimates of...

Post-Closure Inspection Report for the Tonopah Test Range, Nevada: For Calendar Year 2017, Revision 0

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

Alvarado, Juan; Matthews, Patrick

This report provides the results of the annual post-closure inspections conducted at the closed corrective action units (CAUs) located on the Tonopah Test Range (TTR) and the Nevada Test and Training Range (NTTR). This report covers calendar year 2017 and includes visual inspection and repair activities completed at the following CAUs: CAU 400: Bomblet Pit and Five Points Landfill (TTR) CAU 407: Roller Coaster RadSafe Area (TTR) CAU 424: Area 3 Landfill Complexes (TTR) CAU 453: Area 9 UXO Landfill (TTR) CAU 487: Thunderwell Site (TTR) Visual inspections were conducted according to the post-closure plans in the approved closure reportsmore » and subsequent correspondence with the Nevada Division of Environmental Protection. The annual post-closure inspections were conducted on May 23, 2017. No maintenance or repair issues were noted at CAU 400 and CAU 487. Maintenance items and subsequent repairs include the following: CAU 407: A large animal burrow was observed in the southeast corner of the cover during the inspection. Two additional animal burrows were discovered during repair actions. All cover defects were repaired on January 9, 2018. CAU 424: CAS 03-08-002-A304 (Landfill Cell A3-4): A new monument was installed and the subsidence area was repaired on January 9, 2018. CAU 424: CAS 03-08-002-A308 (Landfill Cell A3-8): Lava rock, used to mark the two eastern monument locations, was noted as missing during the inspection. The lava rock was replaced on January 9, 2018. CAU 453: Five large animal burrows, located near the east–central portion of cover, was noted during the inspection. Eight additional animal burrows were discovered during repair actions. All cover defects were repaired on January 9, 2018.« less

Nightguard vital bleaching: side effects and patient satisfaction 10 to 17 years post-treatment.

PubMed

Boushell, Lee W; Ritter, André V; Garland, Glenn E; Tiwana, Karen K; Smith, Lynn R; Broome, Angela; Leonard, Ralph H

2012-06-01

  The long-term patient satisfaction and safety of nightguard vital bleaching (NGVB) requires further evaluation.   The purpose of this study was to evaluate patients' satisfaction and identify side effects of NGVB up to 17 years post-treatment.   Thirty-one participants who had completed previous NGVB studies using 10% carbamide peroxide were contacted at least 10 years post-treatment (range 10-17 years, average 12.3 years). Participants reported shade satisfaction (very satisfied [VS], partially satisfied [PS], or not satisfied [NS]) as well as potential complications. Participants had teeth # 6 to 11 examined for tooth vitality, gingival inflammation (Löe's Gingival Index [GI]), and radiographically for external cervical resorption (ECR).   All of the participants had successful lightening of their teeth. Sixty-one percent (19) had not retreated their teeth. Of those who had not retreated their teeth and who responded to the question of whitening satisfaction, 31% (4/13) were VS, 54% (7/13) were PS, and 15% (2/13) were NS with their current shade. Of those who had retreated their teeth, all were VS or PS. Ninety-one percent of the examined teeth had GI = 0 (normal), 7% had GI = 1 (mild inflammation), and 2% had GI = 2 (moderate inflammation). Sixty-nine percent of teeth tested responded to a cold stimulus. Radiographs did not detect ECR or apical lesions. No participant reported having a gingival biopsy post-treatment, and 87% would whiten again.   Patient satisfaction with NGVB may last as long as 12.3 years in average (range 10-17 years) post-treatment. GI and ECR findings were considered within the normal expectations for the sample studied, suggesting minimal clinical post-NGVB side effects up to 17 years. Nightguard vital bleaching provides patient satisfaction with minimal side effects up to 17 years post-treatment. © 2011 Wiley Periodicals, Inc.

15 CFR 921.12 - Post site selection.

Code of Federal Regulations, 2011 CFR

2011-01-01

... NOAA approval of a proposed site, the state may submit a request for funds to develop the draft... and biological characteristics of the site approved by NOAA necessary for providing EIS information to NOAA. The state's request for these post site selection funds must be accompanied by the information...

15 CFR 921.12 - Post site selection.

Code of Federal Regulations, 2014 CFR

2014-01-01

... NOAA approval of a proposed site, the state may submit a request for funds to develop the draft... and biological characteristics of the site approved by NOAA necessary for providing EIS information to NOAA. The state's request for these post site selection funds must be accompanied by the information...

15 CFR 921.12 - Post site selection.

Code of Federal Regulations, 2013 CFR

2013-01-01

... NOAA approval of a proposed site, the state may submit a request for funds to develop the draft... and biological characteristics of the site approved by NOAA necessary for providing EIS information to NOAA. The state's request for these post site selection funds must be accompanied by the information...

15 CFR 921.12 - Post site selection.

Code of Federal Regulations, 2012 CFR

2012-01-01

... NOAA approval of a proposed site, the state may submit a request for funds to develop the draft... and biological characteristics of the site approved by NOAA necessary for providing EIS information to NOAA. The state's request for these post site selection funds must be accompanied by the information...

15 CFR 921.12 - Post site selection.

Code of Federal Regulations, 2010 CFR

2010-01-01

... NOAA approval of a proposed site, the state may submit a request for funds to develop the draft... and biological characteristics of the site approved by NOAA necessary for providing EIS information to NOAA. The state's request for these post site selection funds must be accompanied by the information...

Arizona Air Quality State Implementation Plans; Final Approval; Douglas, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plan

EPA Pesticide Factsheets

EPA is taking final rulemaking action to approve, as part of the State Implementation Plan (SIP) for the State of Arizona, the second 10-year maintenance plan for the Douglas maintenance area for the 1971 National Ambient Air Quality Standards for SO2.

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

PubMed

Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data

AOA Approval of ACGME Internship and Residency Training.

PubMed

Duffy, Thomas; Martinez, Bulmaro

2011-04-01

Since the 1970s, the American Osteopathic Association (AOA) has provided a means for osteopathic physicians to apply for approval of their postdoctoral training in programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). Osteopathic physicians who trained in ACGME programs need this approval to meet AOA licensure and board certification requirements. The AOA approves ACGME residency training with several different approval processes. Approval of the first year of postdoctoral training occurs through Resolution 42, specialty approval (for specialties in which the first year of training is part of the residency), or federal or military training approval. For residency training, the AOA verifies successful completion of an ACGME training program before approving the training. The AOA is using customer surveys and online applications to improve the review process for applicants.

Post-approval monitoring and oversight of U.S.-initiated human subjects research in resource-constrained countries.

PubMed

Brown, Brandon; Kinsler, Janni; Folayan, Morenike O; Allen, Karen; Cáceres, Carlos F

2014-06-01

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study's investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide.

14 CFR 1264.135 - Post-hearing briefs.

Code of Federal Regulations, 2010 CFR

2010-01-01

... FRAUD CIVIL PENALTIES ACT OF 1986 § 1264.135 Post-hearing briefs. The presiding officer may require the parties to file post-hearing briefs. In any event, upon approval of the presiding officer, any party may... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Post-hearing briefs. 1264.135 Section 1264...

14 CFR 1264.135 - Post-hearing briefs.

Code of Federal Regulations, 2013 CFR

2013-01-01

... FRAUD CIVIL PENALTIES ACT OF 1986 § 1264.135 Post-hearing briefs. The presiding officer may require the parties to file post-hearing briefs. In any event, upon approval of the presiding officer, any party may... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Post-hearing briefs. 1264.135 Section 1264...

14 CFR 1264.135 - Post-hearing briefs.

Code of Federal Regulations, 2012 CFR

2012-01-01

... FRAUD CIVIL PENALTIES ACT OF 1986 § 1264.135 Post-hearing briefs. The presiding officer may require the parties to file post-hearing briefs. In any event, upon approval of the presiding officer, any party may... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Post-hearing briefs. 1264.135 Section 1264...

14 CFR 1264.135 - Post-hearing briefs.

Code of Federal Regulations, 2011 CFR

2011-01-01

... FRAUD CIVIL PENALTIES ACT OF 1986 § 1264.135 Post-hearing briefs. The presiding officer may require the parties to file post-hearing briefs. In any event, upon approval of the presiding officer, any party may... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Post-hearing briefs. 1264.135 Section 1264...

38 CFR 21.5150 - State approving agencies.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false State approving agencies. 21.5150 Section 21.5150 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-Vietnam Era Veterans' Educational Assistance Under...

38 CFR 21.5150 - State approving agencies.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false State approving agencies. 21.5150 Section 21.5150 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-Vietnam Era Veterans' Educational Assistance Under...

38 CFR 21.5150 - State approving agencies.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false State approving agencies. 21.5150 Section 21.5150 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-Vietnam Era Veterans' Educational Assistance Under...

38 CFR 21.5150 - State approving agencies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false State approving agencies. 21.5150 Section 21.5150 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-Vietnam Era Veterans' Educational Assistance Under...

38 CFR 21.5150 - State approving agencies.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false State approving agencies. 21.5150 Section 21.5150 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-Vietnam Era Veterans' Educational Assistance Under...

Bariatric surgery in patients with bipolar spectrum disorders: Selection factors, post-operative visit attendance, and weight outcomes

PubMed Central

Friedman, Kelli E.; Applegate, Katherine; Portenier, Dana; McVay, Megan

2017-01-01

Background As many of 3% of bariatric surgery candidates are diagnosed with a bipolar spectrum disorder. Objectives 1) To describe differences between patients with bipolar spectrum disorders who are approved and not approved for surgery by the mental health evaluator. 2) To examine surgical outcomes of patients with bipolar spectrum disorders. Setting Academic medical center, United States. Methods A retrospective record review was conducted of consecutive patients who applied for bariatric surgery between 2004 and 2009. Patients diagnosed with bipolar spectrum disorders who were approved for surgery (n=42) were compared with patients with a bipolar spectrum disorder who were not approved (n=31) and to matched control surgical patients without a bipolar spectrum diagnosis (n=29) on a variety of characteristics and surgical outcomes. Results Of bariatric surgery candidates diagnosed with a bipolar spectrum disorder who applied for surgery, 57% were approved by the psychologist and 48% ultimately had surgery. Patients with a bipolar spectrum disorder who were approved for surgery were less likely to have had a previous psychiatric hospitalizations than those who were not approved for surgery. Bariatric surgery patients diagnosed with a bipolar spectrum disorder were less likely to attend follow-up care appointments 2 or more years post-surgery compared to matched patients without bipolar disorder. Among patients with available data, those with a bipolar spectrum disorder and matched patients had similar weight loss at 12 months (n=21 for bipolar, n=24 for matched controls) and at 2 or more years (mean=51 months; n=11 for bipolar, n=20 for matched controls). Conclusions Patients diagnosed with a bipolar spectrum disorder have a high rate of delay/denial for bariatric surgery based on the psychosocial evaluation and are less likely to attend medical follow-up care 2 or more years post-surgery. Carefully screened patients with bipolar disorder who engage in long

Male breast cancer: 20-year survival data for post-mastectomy radiotherapy.

PubMed

Eggemann, Holm; Ignatov, Atanas; Stabenow, Roland; von Minckwitz, Gunter; Röhl, Friedrich Wilhelm; Hass, Peter; Costa, Serban-Dan

2013-08-01

The goal of this population-based study was to determine the impact of post-mastectomy radiation therapy on long-term overall survival (OS) of male patients with breast cancer. We investigated 20-year OS rates of 664 patients diagnosed with primary stage I-III breast cancer in former East Germany between 1970 and 1989. Patients had a radical mastectomy with axillary lymph node dissection without systemic adjuvant therapy. Median follow-up time was 26.2 years (range 19-38 years). 52.4% of the patients had post-mastectomy radiotherapy. Radiotherapy showed different effects in each stage group after 20 years. Whereas there was an OS trend for radiotherapy to harm patients with stage I disease (hazard ratio (HR) 1.45; 95% confidence interval (CI) 0.98-2.15; p = 0.065), radiotherapy showed no benefit in patients with stage II disease (HR 0.82; 95% CI 0.62-1.1; p = 0.15). There was a significant survival benefit for patients with stage III disease receiving radiotherapy (HR 0.60; 95% CI 0.41-0.88; p = 0.008). Post-mastectomy radiotherapy is associated with longer OS in male patients with stage III breast cancer. Male breast cancer patients at stages I and II do not seem to benefit from radiotherapy, but obsolete irradiation techniques might explain adverse long-term effects in earlier stages.

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

PubMed

Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

2017-06-01

An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.

PubMed

Yang, Brian W; Iorio, Matthew L; Day, Charles S

2017-03-15

The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.

23 CFR Appendix C to Part 1240 - Certification (Calendar Year 1998 Survey Based on Survey Approved Under 23 U.S.C. 153)

Code of Federal Regulations, 2012 CFR

2012-04-01

... belt use rate reported above is based on a survey whose design was approved by NHTSA, in writing, on or... survey design has remained unchanged since the survey was approved (except to the extent that the... 23 Highways 1 2012-04-01 2012-04-01 false Certification (Calendar Year 1998 Survey Based on Survey...

23 CFR Appendix C to Part 1240 - Certification (Calendar Year 1998 Survey Based on Survey Approved Under 23 U.S.C. 153)

Code of Federal Regulations, 2010 CFR

2010-04-01

... belt use rate reported above is based on a survey whose design was approved by NHTSA, in writing, on or... survey design has remained unchanged since the survey was approved (except to the extent that the... 23 Highways 1 2010-04-01 2010-04-01 false Certification (Calendar Year 1998 Survey Based on Survey...

23 CFR Appendix C to Part 1240 - Certification (Calendar Year 1998 Survey Based on Survey Approved Under 23 U.S.C. 153)

Code of Federal Regulations, 2013 CFR

2013-04-01

... belt use rate reported above is based on a survey whose design was approved by NHTSA, in writing, on or... survey design has remained unchanged since the survey was approved (except to the extent that the... 23 Highways 1 2013-04-01 2013-04-01 false Certification (Calendar Year 1998 Survey Based on Survey...

23 CFR Appendix C to Part 1240 - Certification (Calendar Year 1998 Survey Based on Survey Approved Under 23 U.S.C. 153)

Code of Federal Regulations, 2011 CFR

2011-04-01

... belt use rate reported above is based on a survey whose design was approved by NHTSA, in writing, on or... survey design has remained unchanged since the survey was approved (except to the extent that the... 23 Highways 1 2011-04-01 2011-04-01 false Certification (Calendar Year 1998 Survey Based on Survey...

23 CFR Appendix C to Part 1240 - Certification (Calendar Year 1998 Survey Based on Survey Approved Under 23 U.S.C. 153)

Code of Federal Regulations, 2014 CFR

2014-04-01

... belt use rate reported above is based on a survey whose design was approved by NHTSA, in writing, on or... survey design has remained unchanged since the survey was approved (except to the extent that the... 23 Highways 1 2014-04-01 2014-04-01 false Certification (Calendar Year 1998 Survey Based on Survey...

39 CFR 111.4 - Approval of the Director of the Federal Register.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 39 Postal Service 1 2010-07-01 2010-07-01 false Approval of the Director of the Federal Register. 111.4 Section 111.4 Postal Service UNITED STATES POSTAL SERVICE POST OFFICE SERVICES [DOMESTIC MAIL] GENERAL INFORMATION ON POSTAL SERVICE § 111.4 Approval of the Director of the Federal Register...

Suicidal ideation at 1-year post-stroke: A nationwide survey in China.

PubMed

Yang, Yang; Shi, Yu-Zhi; Zhang, Ning; Wang, Shuo; Ungvari, Gabor S; Ng, Chee H; Wang, Yi-Long; Zhao, Xing-Quan; Wang, Yong-Jun; Wang, Chun-Xue; Xiang, Yu-Tao

Few studies on suicidal ideation have been conducted in post-stroke patients in China. This national study examined suicidal ideation at 1-year post-stroke and explored its demographic and clinical correlates. A total of 1418 patients with ischemic stroke were included in 56 hospitals nationwide. Demographic, clinical characteristics and neuro-imaging information were collected with standardized instruments, including assessment of stroke severity, depression, cognitive impairment, stroke recurrence, physical disability and insomnia. Suicidal ideation was measured using item 3 of the Hamilton Rating Scale for Depression. The frequency of suicidal ideation in this study was 6.6%. Multivariate analyses revealed that disability (OR=2.07, 95% CI=1.09-3.05), stroke recurrence (OR=4.13, 95% CI=1.74-9.77) and insomnia early (OR=1.87, 95% CI=1.03-3.39), middle (OR=2.66, 95% CI=1.46-4.85) and late (OR=2.35, 95% CI=1.31-4.19) at the 1-year follow-up and post-stroke depression (OR=2.16, 95% CI=1.23-3.82) were significantly associated with post-stroke suicidal ideation. Post-stroke depression, disability, insomnia and stroke recurrence are possible risk factors of suicidal ideation that warrant attention in clinical practice. Copyright © 2016 Elsevier Inc. All rights reserved.

10 CFR 52.147 - Duration of design approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Duration of design approval. 52.147 Section 52.147 Energy... Standard Design Approvals § 52.147 Duration of design approval. A standard design approval issued under this subpart is valid for 15 years from the date of issuance and may not be renewed. A design approval...

Post-silking Factor Consequences for N Efficiency Changes Over 38 Years of Commercial Maize Hybrids.

PubMed

Chen, Keru; Vyn, Tony J

2017-01-01

Hybrid selection in maize ( Zea mays L.) over the decades has increased post-silking dry matter (PostDM) and nitrogen (PostN) accumulation, often with an accompanying increase in one or more N use efficiency (NUE) metrics such as partial factor productivity (PFP), N conversion efficiency (NCE), and N internal efficiency (NIE). More certainty on the underlying mechanisms of how PostDM and PostN changes over time have contributed to NUE gains or losses in modern-era hybrids can only be realized by directly comparing hybrids of different eras in the context of production-system-relevant management systems. A two-year and two-location field study was conducted in Indiana with two N rates (55 and 220 kg N ha -1 ), three plant densities (54,000, 79,000, and 104,000 plants ha -1 ) and eight commercial hybrids that were released by a single seed company from 1967 to 2005. The main treatment effects of N rate, density, and hybrid dominated the PostDM and PostN responses, and there were no significant two-way or three-way interactions. Total dry matter at maturity gains averaged 80 kg ha -1 year -1 of hybrid release when averaged over locations, plant densities and N rates. Total N contents at maturity increased 0.68 kg ha -1 year -1 , primarily due to annual increases in grain N content (0.8 kg ha -1 year -1 ). Post-silking N uptake rate increased 0.44 kg ha -1 year -1 for these era hybrids in more favorable production site-years. Slopes of grain N concentration increases per unit PostN gain were similar for all hybrids. Gains in average PFP over time were considerably higher at the low N rate (0.9 kg ha -1 year -1 ) than at the high N rate (0.3 kg kg -1 year -1 ). Hybrid gains in NIE were evident from 1967 to 1994, but not thereafter. The low N rate and higher plant densities also increased relative NIE and NCE values, but without hybrid interactions. There was no consistent trend of NIE or NCE gains in these hybrids primarily because grain and whole-plant N concentrations

FDA Expands Approval of Brentuximab for Hodgkin Lymphoma

Cancer.gov

The FDA has expanded the approved uses of brentuximab (Adcetris) in people with Hodgkin lymphoma. As this Cancer Currents post explains, it can now be used in combination with three chemotherapy drugs as an initial treatment in patients with advanced disease.

45 CFR 680.12 - One-year NSF post-employment restrictions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Section 680.12 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION NATIONAL SCIENCE FOUNDATION RULES OF PRACTICE AND STATUTORY CONFLICT-OF-INTEREST EXEMPTIONS Rules of Practice for the National Science Foundation § 680.12 One-year NSF post-employment restrictions...

14 CFR § 1264.135 - Post-hearing briefs.

Code of Federal Regulations, 2014 CFR

2014-01-01

... PROGRAM FRAUD CIVIL PENALTIES ACT OF 1986 § 1264.135 Post-hearing briefs. The presiding officer may require the parties to file post-hearing briefs. In any event, upon approval of the presiding officer, any... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Post-hearing briefs. § 1264.135 Section Â...

Periprosthetic bleeding 18 years post-silicone reconstruction of the orbital floor.

PubMed

Ilie, Vlad Ionut; Ilie, Victor George; Quarmby, Craig; Lefter, Mihaela

2011-10-01

Periprosthetic orbital haemorrhage is an uncommon complication of the alloplastic implants used in post-traumatic orbital floor repair. The small case series or individual reports provide no definite causative explanation for this delayed bleeding around silicone implants. It is likely that it is related to the disruption of fine capillaries within the pseudocapsule surrounding the implant, since the material does cause low-grade irritation with evidence of chronic inflammation. We report the case of a patient who developed a spontaneous periprosthetic bleeding 18 years' post-silicone sheet reconstruction of the orbital floor. Urgent removal of the implant insured prompt resolution of all symptoms and no further problem during the 2-year follow-up. This report emphasizes that periprosthetic orbital haemorrhage can occur years after the initial repair. Awareness of this rare complication allows for prompt diagnosis, decreasing the possibility of permanent damage of the orbital content. The removal of implant is necessary to relieve the symptoms and prevent potential infective complications.

Science, space budget approved

NASA Astrophysics Data System (ADS)

Maggs, William Ward

The Senate is about to approve a budget for NASA, NSF, and other independent agencies that would restore some of the money cut by the House version from President Bush's request.The Senate Appropriations Committee approved recommendations of its Veterans Affairs, Housing and Urban Development, and Independent Agencies (VAHUDIA) subcommittee on $48.05 billion in discretionary spending for Fiscal Year 1990 on September 13. The full Senate could vote on the bill in the next few weeks. Differences between House and Senate versions of the bill will then be worked out by members of both houses in conference later in the year.

48 CFR 22.404-10 - Posting wage determinations and notice.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Posting wage... Contracts Involving Construction 22.404-10 Posting wage determinations and notice. The contractor must keep a copy of the applicable wage determination (and any approved additional classifications) posted at...

Ornamental Horticulture Technology; Suggested 2-Year Post High School Curriculums.

ERIC Educational Resources Information Center

Bureau of Adult, Vocational, and Technical Education (DHEW/OE), Washington, DC. Div. of Vocational and Technical Education.

Developed by a technical education specialist, this guide is designed to aid school administrators in planning and developing 2-year post-high school programs or evaluating existing programs in ornamental horticulture technology. In addition to general information on the program, contents include course outlines with examples of tests and…

Epidemiology of post-adolescence acne and adolescence acne in Singapore: a 10-year retrospective and comparative study.

PubMed

Han, X D; Oon, H H; Goh, C L

2016-10-01

Acne vulgaris commonly affects adolescents. But recent reports suggest a rising prevalence of post-adolescence acne. While there are few reports on post-adolescence acne, there are even fewer reports comparing adolescence acne and post-adolescence. Epidemiological data of adolescence (<25 years) and post-adolescence (≥25 years) acne patients diagnosed between 2004 and 2013 in a tertiary dermatology referral centre was analysed. From the pool of patients seen in 2010, 80 adolescence and 84 post-adolescence acne patients' epidemiological characteristics and treatment responses were analysed. During the 10-year study period, there was an increase in the number and proportion of acne cases. In 2004, 4447 (5.77%) of all new diagnoses made were of acne vulgaris. The proportion rose to 5723 (8.13%) in 2013. There were consistently more female than male acne patients. The proportion of post-adolescent cases remained constant at about 30% of all acne patients seen. Mean age of acne vulgaris patients decreased from 23.1 years in 2004 to 22.6 years in 2013. In the subgroup analysis, there were more males than females with adolescence acne (61.3% vs. 38.8%, P < 0.01) and more females with post-adolescence acne (69.0% vs. 31.0%, P < 0.01). Thirty-four (40.5%) post-adolescence acne patients had acne from adolescence persisting into adulthood. Comedonal acne was more prevalent in the adolescence acne patients (58.8% vs. 40.5%, P = 0.019), whereas cystic acne was more prevalent in post-adolescence patients (18.1% vs. 7.5%, P = 0.044). Systemic retinoids were more often used for treatment in the adolescence acne patients than post-adolescence acne patients (23.8% vs. 10.7%, P = 0.027). Acne predominantly affects adolescents but post-adolescence acne is not uncommon. For post-adolescence acne, females predominate over males. Inflammatory and cystic acne tends to be more predominant in post-adolescence acne patients, whereas comedonal acne is more often seen in adolescence acne

7 CFR 1717.608 - RUS approval of contracts.

Code of Federal Regulations, 2014 CFR

2014-01-01

... engineering services, and in 7 CFR part 1726 for construction and procurement. (b) Large retail power contracts. RUS approval of contracts to sell electric power to retail customers is required only if the... AGRICULTURE POST-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND GUARANTEED ELECTRIC LOANS Operational...

7 CFR 1717.608 - RUS approval of contracts.

Code of Federal Regulations, 2013 CFR

2013-01-01

... engineering services, and in 7 CFR part 1726 for construction and procurement. (b) Large retail power contracts. RUS approval of contracts to sell electric power to retail customers is required only if the... AGRICULTURE POST-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND GUARANTEED ELECTRIC LOANS Operational...

7 CFR 1717.608 - RUS approval of contracts.

Code of Federal Regulations, 2012 CFR

2012-01-01

... engineering services, and in 7 CFR part 1726 for construction and procurement. (b) Large retail power contracts. RUS approval of contracts to sell electric power to retail customers is required only if the... AGRICULTURE POST-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND GUARANTEED ELECTRIC LOANS Operational...

Rucaparib Approved as Maintenance Therapy for Ovarian Cancer

Cancer.gov

FDA has expanded its approval of rucaparib for women with ovarian, fallopian tube, or primary peritoneal cancer. As this Cancer Currents blog post explains, it can now be used to treat women with recurrent disease whose tumors shrank after subsequent treatment with a platinum-based chemotherapy.

One year follow-up of post-partum-onset depression: the role of depressive symptom severity and personality disorders.

PubMed

Uguz, Faruk; Akman, Cemal; Sahingoz, Mine; Kaya, Nazmiye; Kucur, Rahim

2009-06-01

Long-term follow-up and risk factors of persistent post-partum depression (PPD) are fairly unknown compared with its prevalence in the developing countries. In this study, we did a follow-up measure of PPD and examined the factors, which were associated with PPD 1-year post-partum. Our sample comprised of 34 women. Depressive symptoms were assessed by the Edinburgh post-natal depression scale (EPDS) 6 weeks post-partum, and women with scores >12 on this scale was categorised as depressed. Personality disorders were determined at the same occasion by means of the Structured Clinical Interview for DSM-III-R personality disorders (SCID-II). One year post-partum EPDS was completed. The rate of PPD 1-year post-partum was 32.4%, and it was unrelated to age at assessment, primiparity, number of children, employment status, economical status and educational level. Women depressed 1-year post-partum had significantly higher basal scores of EPDS and more often also a diagnosis of any axis II disorder; and specifically dependent and obsessive-compulsive personality disorders. In our sample, the predictors of 1-year post-partum PPD were having higher basal score of EPDS and the existence of a personality disorder. This study suggests that women with PPD, scoring high in the EPDS scale 6 weeks post-partum and having a personality disorder, run a higher risk for depression at 1-year follow-up.

Changes in Inmates’ Substance Use and Dependence From Pre-Incarceration to One Year Post-Release

PubMed Central

Tangney, June P.; Folk, Johanna B.; Graham, David M.; Stuewig, Jeffrey B.; Blalock, Daniel V.; Salatino, Andrew; Blasko, Brandy B.; Moore, Kelly E.

2016-01-01

Purpose To assess changes in inmates’ misuse of substances from pre- to post-incarceration. Methods In Study 1, professionals (n = 162) and laypersons (n = 50) predicted how jail inmates’ substance misuse would change from pre-incarceration to post-release. In Study 2, a longitudinal study of 305 jail inmates, we examined actual changes in substance use and dependence from pre-incarceration to the first year post-incarceration, as well as whether changes varied as a function of demographic, criminal justice, treatment, and personality factors. Results Professionals and laypersons predicted little change in substance misuse whereas, in fact, inmates’ frequency of substance use and dependence decreased substantially from pre-incarceration to post-release. Sharper decreases were observed for inmates who were female, younger, more educated, serving longer sentences, enrolled in substance abuse treatment, high in shame-proneness, and low in criminogenic thinking. Race, first time incarceration, transfer to other correctional facilities, mandated community supervision (probation), and guilt-proneness did not predict changes in substance use or dependence. Conclusions Although substance misuse decreased, this remains a population high in need of substance abuse treatment both upon arrest and at one year post-incarceration; 60% of former inmates met at least one DSM-IV criterion for substance dependence at one year post-release. PMID:27458324

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

PubMed

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

PubMed Central

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

Midwest Guardrail System (MGS) with southern yellow pine posts.

DOT National Transportation Integrated Search

2013-09-01

The Midwest Guardrail System (MGS) has previously been approved for use with various alternative species of wood posts. However, Southern Yellow Pine (SYP) is the most common wood guardrail post material in the United States. The goal of this researc...

Two years post-tsunami in Thailand: who still needs assistance?

PubMed

Isaranuwatchai, Wanrudee; Guerriere, Denise; Andrews, Gavin J; Coyte, Peter C

2013-06-01

On 26 December 2004, 280 000 people lost their lives in the Asia-Pacific region. A massive earthquake struck Indonesia, triggering a tsunami that affected several countries, including Thailand. This tsunami had important implications for the health status of Thai citizens and health planning, and thus there is a need to study its long-term impact. This cohort study identified determinants of health service utilization (outpatient services, inpatient services, home care, medications and informal care) 1 and 2 years post-tsunami in Thailand. A two-part model with a multivariate logistic regression for each part was used to identify determinants of the propensity and intensity of utilization. Of 1943 participants, 1889 (97.2%) participated at 1 year and 1814/1889 (96.0%) at 2 years. Common determinants of health service utilization in post-tsunami settings were age, marital status, education level, employment status, number of health conditions and (physical and mental) health status. Knowing the determinants of health service use, health providers may be able to establish programmes for, or to carefully monitor populations, who are more likely to use services. The study results may be used to inform requests for health resources or to assist the development of guidelines for long-term disaster recovery planning.

Accelerated approval of oncology products: the food and drug administration experience.

PubMed

Johnson, John R; Ning, Yang-Min; Farrell, Ann; Justice, Robert; Keegan, Patricia; Pazdur, Richard

2011-04-20

We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations allowed accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. Failure to complete postapproval trials to confirm clinical benefit with due diligence could result in removal of the accelerated approval indication from the market. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in postapproval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8-12.6 years) and the mean time was 4.7 years, representing a substantial time savings in terms of earlier availability of drugs to cancer patients. Three new indications did not show clinical benefit when confirmatory postapproval trials were completed and were subsequently removed from the market or had restricted distribution plans implemented. Confirmatory trials were not completed for 14 new indications. The five longest intervals from receipt of accelerated approval to July 1, 2010, without completion of trials to confirm clinical benefit were 10.5, 6.4, 5.5, 5.5, and 4.7 years. The five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years. Trials to confirm clinical benefit should be part of the drug development plan and should be in progress at the time of an application seeking accelerated approval to prevent an ineffective drug from remaining on the market for an unacceptable time.

Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

PubMed

Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

2017-12-01

Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at

Change in physical mobility over 10 years in post-polio syndrome.

PubMed

Bickerstaffe, A; Beelen, A; Nollet, F

2015-03-01

Post-polio syndrome is characterised by progressive muscle weakness and other symptoms which can limit physical mobility. We assessed the rate of decline in mobility over 10 years in relation to strength decline; and investigated potential predictors for the rate of decline of walking capacity, a measure of mobility, in 48 patients with post-polio syndrome and proven quadriceps dysfunction at baseline. Average walking capacity and self-reported physical mobility declined over 10 years, by 6 and 14%, respectively. Concomitantly people lost an average of 15% of isometric quadriceps strength. Significantly more people used walking aids offering greater support at follow-up. Notably, there was much individual variation, with 18% of participants losing a substantial amount of walking capacity (27% decline) and concomitant self-reported physical mobility (38% decline). Loss of quadriceps strength only explained a small proportion of the variance of the decline in walking capacity (R = 11%) and the rate of decline could not be predicted from baseline values for strength, walking capacity, self-reported physical mobility or basic demographics. The individual variability, yet lack of predictive factors, underscores the need for personally tailored care based on actual functional decline in patients with post-polio syndrome. Copyright © 2014. Published by Elsevier B.V.

Herpes zoster vaccine live: A 10 year review of post-marketing safety experience

PubMed Central

Willis, English D.; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W.; Halsey, Neal A.; Gershon, Anne A.

2017-01-01

Background Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. Methods All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. Results A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (<1%) with 38% occurring in immunocompromised individuals. All reports of disseminated HZ confirmed by PCR as VZV Oka/Merck vaccine-strain were in individuals with immunosuppressive conditions and/or therapy at the time of vaccination. Conclusions The safety profile of ZVL, following 10 years of post-marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. PMID:29174682

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

PubMed

Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

2017-01-01

The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P < .001). Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

46 CFR 154.1862 - Posting of speed reduction.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 5 2010-10-01 2010-10-01 false Posting of speed reduction. 154.1862 Section 154.1862... STANDARDS FOR SELF-PROPELLED VESSELS CARRYING BULK LIQUEFIED GASES Operations § 154.1862 Posting of speed reduction. If a speed reduction is specially approved by the Commandant under § 154.409, the master shall...

46 CFR 154.1862 - Posting of speed reduction.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 5 2011-10-01 2011-10-01 false Posting of speed reduction. 154.1862 Section 154.1862... STANDARDS FOR SELF-PROPELLED VESSELS CARRYING BULK LIQUEFIED GASES Operations § 154.1862 Posting of speed reduction. If a speed reduction is specially approved by the Commandant under § 154.409, the master shall...

40 CFR 265.145 - Financial assurance for post-closure care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... of this section in accordance with § 265.145(h). (e) Financial test and corporate guarantee for post... closure and post-closure cost estimates to be covered by the test; (iv) Specify the date ending the owner... Regional Administrator may approve a decrease in the current post-closure cost estimate for which this test...

40 CFR 265.145 - Financial assurance for post-closure care.

Code of Federal Regulations, 2010 CFR

2010-07-01

... of this section in accordance with § 265.145(h). (e) Financial test and corporate guarantee for post... closure and post-closure cost estimates to be covered by the test; (iv) Specify the date ending the owner... Regional Administrator may approve a decrease in the current post-closure cost estimate for which this test...

40 CFR 265.145 - Financial assurance for post-closure care.

Code of Federal Regulations, 2012 CFR

2012-07-01

... of this section in accordance with § 265.145(h). (e) Financial test and corporate guarantee for post... closure and post-closure cost estimates to be covered by the test; (iv) Specify the date ending the owner... Regional Administrator may approve a decrease in the current post-closure cost estimate for which this test...

40 CFR 265.145 - Financial assurance for post-closure care.

Code of Federal Regulations, 2014 CFR

2014-07-01

... of this section in accordance with § 265.145(h). (e) Financial test and corporate guarantee for post... closure and post-closure cost estimates to be covered by the test; (iv) Specify the date ending the owner... Regional Administrator may approve a decrease in the current post-closure cost estimate for which this test...

40 CFR 265.145 - Financial assurance for post-closure care.

Code of Federal Regulations, 2011 CFR

2011-07-01

... of this section in accordance with § 265.145(h). (e) Financial test and corporate guarantee for post... closure and post-closure cost estimates to be covered by the test; (iv) Specify the date ending the owner... Regional Administrator may approve a decrease in the current post-closure cost estimate for which this test...

Negative outcomes after liver transplantation in patients with alcoholic liver disease beyond the fifth post-transplant year.

PubMed

Grąt, Michał; Lewandowski, Zbigniew; Grąt, Karolina; Wronka, Karolina Maria; Krasnodębski, Maciej; Barski, Krzysztof; Zborowska, Hanna; Patkowski, Waldemar; Zieniewicz, Krzysztof; Krawczyk, Marek

2014-10-01

Although up to 50% of patients with alcoholic liver disease (ALD) resume alcohol consumption after liver transplantation (LT), numerous studies indicate that long-term results are not compromised. This study focused on evaluating the impact of ALD on outcomes up to and beyond the fifth year after LT. Among the 432 primary LT recipients included in this study, 97 underwent transplantation for ALD. Alcohol relapse rate at 10 yr was 33.5%, with younger recipient age being the only independent predictor (p = 0.019). Survival of patients with ALD (77.0%) was similar to those without (79.0%) up to the fifth post-transplant year (p = 0.655) but worse during the five subsequent years among the five-yr survivors (70.6% vs. 92.9%; p = 0.002). ALD was an independent risk factor for poorer survival beyond the fifth post-transplant year (p = 0.049), but not earlier (p = 0.717). Conversely, alcohol relapse increased the risk of death only during the first five post-transplant years (p = 0.039). There were no significant differences regarding graft failure incidence between ALD and non-ALD recipients up to the fifth post-transplant year (7.3% vs. 11.6%; p = 0.255) and beyond (12.9% vs. 5.0%; p = 0.126). In conclusion, pre-transplant diagnosis of ALD yields negative effects on post-transplant outcomes beyond the fifth post-transplant year, not attributable to recidivism. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Atypical presentation of macrophagic myofasciitis 10 years post vaccination.

PubMed

Ryan, Aisling M; Bermingham, Niamh; Harrington, Hugh J; Keohane, Catherine

2006-12-01

Macrophagic myofasciitis (MMF) is an uncommon inflammatory disorder of muscle believed to be due to persistence of vaccine-derived aluminium hydroxide at the site of injection. The condition is characterised by diffuse myalgias, arthralgia and fatigue. We describe a patient with histologically confirmed MMF whose presentation was atypical with left chest and upper limb pain beginning more than 10 years post vaccination. Treatment with steroids led to symptomatic improvement. Although rare, clinicians should consider MMF in cases of atypical myalgia.

Weight-related self-efficacy in relation to maternal body weight from early pregnancy to 2 years post-partum

PubMed Central

Lipsky, Leah M.; Strawderman, Myla S.; Olson, Christine M.

2016-01-01

Excessive gestational weight gain may lead to long-term increases in maternal body weight and associated health risks. The purpose of this study was to examine the relationship between maternal body weight and weight-related self-efficacy from early pregnancy to 2 years post-partum. Women with live, singleton term infants from a population-based cohort study were included (n = 595). Healthy eating self-efficacy and weight control self-efficacy were assessed prenatally and at 1 year and 2 years post-partum. Body weight was measured at early pregnancy, before delivery, and 6 weeks, 1 year and 2 years post-partum. Behavioural (smoking, breastfeeding) and sociodemographic (age, education, marital status, income) covariates were assessed by medical record review and baseline questionnaires. Multi-level linear regression models were used to examine the longitudinal associations of self-efficacy measures with body weight. Approximately half of the sample (57%) returned to early pregnancy weight at some point by 2 years post-partum, and 9% became overweight or obese at 2 years post-partum. Body weight over time was inversely related to healthy eating (β = −0.57, P = 0.02) and weight control (β = −0.99, P < 0.001) self-efficacy in the model controlling for both self-efficacy measures as well as time and behavioural and sociodemographic covariates. Weight-related self-efficacy may be an important target for interventions to reduce excessive gestational weight gain and post-partum weight gain. PMID:25244078

Cognitive activity limitations one year post-trauma in patients admitted to sub-acute rehabilitation after severe traumatic brain injury.

PubMed

Sommer, Jens Bak; Norup, Anne; Poulsen, Ingrid; Morgensen, Jesper

2013-09-01

To examine cognitive activity limitations and predictors of outcome 1 year post-trauma in patients admitted to sub-acute rehabilitation after severe traumatic brain injury. The study included 119 patients with severe traumatic brain injury admitted to centralized sub-acute rehabilitation in the Eastern part of Denmark during a 5-year period from 2005 to 2009. Level of consciousness was assessed consecutively during rehabilitation and at 1 year post-trauma. Severity of traumatic brain injury was classified according to duration of post-traumatic amnesia. The cognitive subscale of Functional Independence MeasureTM (Cog-FIM) was used to assess cognitive activity limitations. Multivariate logistic regression analyses were performed to identify predictors of an independent level of functioning. The majority of patients progressed to a post-confusional level of consciousness during the first year post-trauma. At follow-up 33-58% of patients had achieved functional independence within the cognitive domains on the Cog-FIM. Socio-economic status, duration of acute care and post-traumatic amnesia were significant predictors of outcome. Substantial recovery was documented among patients with severe traumatic brain injury during the first year post-trauma. The results of the current study suggest that absence of consciousness at discharge from acute care should not preclude patients from being referred to specialized sub-acute rehabilitation.

Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).

PubMed

Starling, Randall C; Naka, Yoshifumi; Boyle, Andrew J; Gonzalez-Stawinski, Gonzalo; John, Ranjit; Jorde, Ulrich; Russell, Stuart D; Conte, John V; Aaronson, Keith D; McGee, Edwin C; Cotts, William G; DeNofrio, David; Pham, Duc Thinh; Farrar, David J; Pagani, Francis D

2011-05-10

The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication. After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months

Weight-related self-efficacy in relation to maternal body weight from early pregnancy to 2 years post-partum.

PubMed

Lipsky, Leah M; Strawderman, Myla S; Olson, Christine M

2016-07-01

Excessive gestational weight gain may lead to long-term increases in maternal body weight and associated health risks. The purpose of this study was to examine the relationship between maternal body weight and weight-related self-efficacy from early pregnancy to 2 years post-partum. Women with live, singleton term infants from a population-based cohort study were included (n = 595). Healthy eating self-efficacy and weight control self-efficacy were assessed prenatally and at 1 year and 2 years post-partum. Body weight was measured at early pregnancy, before delivery, and 6 weeks, 1 year and 2 years post-partum. Behavioural (smoking, breastfeeding) and sociodemographic (age, education, marital status, income) covariates were assessed by medical record review and baseline questionnaires. Multi-level linear regression models were used to examine the longitudinal associations of self-efficacy measures with body weight. Approximately half of the sample (57%) returned to early pregnancy weight at some point by 2 years post-partum, and 9% became overweight or obese at 2 years post-partum. Body weight over time was inversely related to healthy eating (β = -0.57, P = 0.02) and weight control (β = -0.99, P < 0.001) self-efficacy in the model controlling for both self-efficacy measures as well as time and behavioural and sociodemographic covariates. Weight-related self-efficacy may be an important target for interventions to reduce excessive gestational weight gain and post-partum weight gain. © 2014 John Wiley & Sons Ltd.

A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors

PubMed Central

Shah, Rashmi R; Roberts, Samantha A; Shah, Devron R

2013-01-01

We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations. PMID:23362829

Corneal collagen crosslinking for corneal ectasia of post-LASIK: one-year results

PubMed Central

Li, Gang; Fan, Zheng-Jun; Peng, Xiu-Jun

2012-01-01

AIM To evaluate the efficacy and safety of corneal collagen crosslinking (CXL) to prevent the progression of post-laser in situ keratomileusis (LASIK) corneal ectasia. METHODS In a prospective, nonrandomized, single-centre study, CXL was performed in 20 eyes of 11 patients who had LASIK for myopic astigmatism and subsequently developed keratectasia.The procedure included instillation of 0.1% riboflavin-20% dextrane solution 30 minutes before UVA irradiation and every 5 minutes for an additional 30 minutes during irradiation. The eyes were evaluated preoperatively and at 1-, 3-, 6-, and 12-month intervals. The complete ophthalmologic examination comprised uncorrected visual acuity, best spectacle-corrected visual acuity, endothelial cell count, ultrasound pachymetry, corneal topography, and in vivo confocal microscopy. RESULTS CXL appeared to stabilise or partially reverse the progression of post-LASIK corneal ectasia without apparent complication in our cohort. UCVA and BCVA improvements were statistically significant(P<0.05) beyond 12 months after surgery (improvement of 0.07 and 0.13 logMAR at 1 year, respectively). Mean baseline flattest meridian keratometry and mean steepest meridian keratometry reduction (improvement of 2.00 and 1.50 diopters(D), respectively) were statistically significant (P<0.05) at 12 months postoperatively. At 1 year after CXL, mean endothelial cell count did not deteriorate. Mean thinnest cornea pachymetry increased significantly. CONCLUSION The results of the study showed a long-term stability of post-LASIK corneal ectasia after crosslinking without relevant side effects. It seems to be a safe and promising procedure to stop the progression of post-LASIK keratectasia, thereby avoiding or delaying keratoplasty. PMID:22762048

24 CFR 202.5 - General approval standards.

Code of Federal Regulations, 2011 CFR

2011-04-01

... years from the date that the materials are circulated or used to advertise. (3) Non-FHA-approved entities. A lender or mortgagee that accepts a loan application from a non-FHA-approved entity must confirm..., including, but not limited to, mergers, terminations, name, location, control of ownership, and character of...

24 CFR 202.5 - General approval standards.

Code of Federal Regulations, 2013 CFR

2013-04-01

... years from the date that the materials are circulated or used to advertise. (3) Non-FHA-approved entities. A lender or mortgagee that accepts a loan application from a non-FHA-approved entity must confirm..., including, but not limited to, mergers, terminations, name, location, control of ownership, and character of...

24 CFR 202.5 - General approval standards.

Code of Federal Regulations, 2012 CFR

2012-04-01

... years from the date that the materials are circulated or used to advertise. (3) Non-FHA-approved entities. A lender or mortgagee that accepts a loan application from a non-FHA-approved entity must confirm..., including, but not limited to, mergers, terminations, name, location, control of ownership, and character of...

38 CFR 21.9590 - Approved programs of education and courses.

Code of Federal Regulations, 2011 CFR

2011-07-01

... licensing or certification test designed to help the individual maintain employment in a vocation or... VETERANS AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approved Programs of... certification test, for which he or she is requesting reimbursement; or (5) Be an individual who has taken a...

38 CFR 21.9590 - Approved programs of education and courses.

Code of Federal Regulations, 2012 CFR

2012-07-01

... licensing or certification test designed to help the individual maintain employment in a vocation or... VETERANS AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approved Programs of... certification test, for which he or she is requesting reimbursement; or (5) Be an individual who has taken a...

38 CFR 21.9590 - Approved programs of education and courses.

Code of Federal Regulations, 2014 CFR

2014-07-01

... licensing or certification test designed to help the individual maintain employment in a vocation or... VETERANS AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approved Programs of... certification test, for which he or she is requesting reimbursement; or (5) Be an individual who has taken a...

38 CFR 21.9590 - Approved programs of education and courses.

Code of Federal Regulations, 2010 CFR

2010-07-01

... licensing or certification test designed to help the individual maintain employment in a vocation or... VETERANS AFFAIRS (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approved Programs of... certification test, for which he or she is requesting reimbursement; or (5) Be an individual who has taken a...

Poor Self-Reported Sleep Quality Predicts Mortality within One Year of Inpatient Post-Acute Rehabilitation among Older Adults

PubMed Central

Martin, Jennifer L.; Fiorentino, Lavinia; Jouldjian, Stella; Mitchell, Michael; Josephson, Karen R.; Alessi, Cathy A.

2011-01-01

Study Objective: To evaluate the association between self-reported sleep quality among older adults during inpatient post-acute rehabilitation and one-year survival. Design: Prospective, observational cohort study. Setting: Two inpatient post-acute rehabilitation sites (one community and one Veterans Administration). Participants: Older patients (aged ≥ 65 years, n = 245) admitted for inpatient post-acute rehabilitation. Interventions: None. Measurements and Results: Within one year of post-acute rehabilitation, 57 participants (23%) were deceased. Cox proportional hazards models showed that worse Pittsburgh Sleep Quality Index (PSQI) total scores during the post-acute care stay were associated with increased mortality risk when controlling for amount of rehabilitation therapy received, comorbidities, and cognitive functioning (Hazard ratio [95% CI] = 1.11 [1.02-1.20]). Actigraphically estimated sleep was unrelated to mortality risk. Conclusions: Poorer self-reported sleep quality, but not objectively estimated sleep parameters, during post-acute rehabilitation was associated with shorter survival among older adults. This suggests self-reported poor sleep may be an important and potentially modifiable risk factor for negative outcomes in these vulnerable older adults. Studies of interventions to improve sleep quality during inpatient rehabilitation should therefore be undertaken, and the long-term health benefits of improved sleep should be explored. Citation: Martin JL; Fiorentino L; Jouldjian S; Mitchell M; Josephson KR; Alessi CA. Poor self-reported sleep quality predicts mortality within one year of inpatient post-acute rehabilitation among older adults. SLEEP 2011;34(12):1715-1721. PMID:22131610

30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

Code of Federal Regulations, 2010 CFR

2010-07-01

... approval or disapproval of the machine. (a) If the qualified electrical representative recommends field..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or...

30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

Code of Federal Regulations, 2011 CFR

2011-07-01

... approval or disapproval of the machine. (a) If the qualified electrical representative recommends field..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or...

49 CFR 451.16 - Action by approval authority-individual approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

49 CFR 451.16 - Action by approval authority-individual approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

49 CFR 451.16 - Action by approval authority-individual approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

49 CFR 451.16 - Action by approval authority-individual approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

49 CFR 451.16 - Action by approval authority-individual approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.

PubMed

Willis, English D; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W; Halsey, Neal A; Gershon, Anne A

2017-12-19

Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (<1%) with 38% occurring in immunocompromised individuals. All reports of disseminated HZ confirmed by PCR as VZV Oka/Merck vaccine-strain were in individuals with immunosuppressive conditions and/or therapy at the time of vaccination. The safety profile of ZVL, following 10 years of post-marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

Amprenavir, new protease inhibitor, approved.

PubMed

James, J S

1999-05-07

A new protease inhibitor, amprenavir (Agenerase), has received FDA marketing approval. The approval was based on two 24-week controlled trials and safety data in more than 1,400 patients under FDA accelerated-approval rules. Amprenavir is approved for patients 4 years of age and older. The drug is taken twice daily, with or without food. Side effects include gastrointestinal disturbances, rashes, and oral paresthesia. Severe or life-threatening rashes have occurred in 1 percent of all patients. Pregnant women should not use the drug unless necessary. The drug was developed by Vertex Pharmaceuticals Inc. and is being marketed by Glaxo Wellcome. Some studies suggest that amprenavir is less likely than other protease inhibitors to be associated with lipid metabolism problems. It may have a resistance profile different from that of other protease inhibitors, and therefore may cause different cross resistance problems. Amprenavir appears to be synergistic with abacavir (Ziagen) in laboratory tests.

Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

PubMed

Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

2015-01-01

Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

Coercion and Reconciliation: Post-Conflict Resolution After the American Civil War

DTIC Science & Technology

2016-05-26

Approved for public release; distribution is unlimited Coercion and Reconciliation: Post -Conflict Resolution After the American Civil War A...Reconciliation: Post -Conflict Resolution After 5a. CONTRACT NUMBER The American Civil War 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6...policies. The conclusion is that during post -conflict resolution, having a moderate coercive body to maintain security, while allowing for political

Iatrogenic trigeminal post-traumatic neuropathy: a retrospective two-year cohort study.

PubMed

Klazen, Y; Van der Cruyssen, F; Vranckx, M; Van Vlierberghe, M; Politis, C; Renton, T; Jacobs, R

2018-06-01

With the growing demand for dental work, trigeminal nerve injuries are increasingly common. This retrospective cohort study examined 53 cases of iatrogenic trigeminal nerve injury seen at the Department of Oral and Maxillofacial Surgery, University Hospitals of Leuven between 2013 and 2014 (0.6% among 8845 new patient visits). Patient records were screened for post-traumatic trigeminal nerve neuropathy caused by nerve injury incurred during implant surgery, endodontic treatment, local anaesthesia, tooth extraction, or specifically third molar removal. The patients ranged in age from 15 to 80years (mean age 42.1years) and 68% were female. The referral delay ranged from 1day to 6.5years (average 10months). The inferior alveolar nerve (IAN) was most frequently injured (28 cases), followed by the lingual nerve (LN) (21 cases). Most nerve injuries were caused during third molar removal (24 cases), followed by implant placement (nine cases) and local anaesthesia injuries (nine cases). Pain symptoms were experienced by 54% of patients suffering IAN injury, compared to 10% of patients with LN injury. Persistent neurosensory disturbances were identified in 60% of patients. While prevention remains the key issue, timely referral seems to be a critical factor for the successful treatment of post-traumatic neuropathy. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Common symptoms during pregnancy to predict depression and health status 14 years post partum.

PubMed

Khatun, Mohsina; Clavarino, Alexandra M; Callaway, Leonie; Alati, Rosa; Najman, Jake M; Williams, Gail; Al Mamun, Abdullah

2009-03-01

To examine the prospective association between symptoms commonly experienced during pregnancy and the mental and general health status of women 14 years post partum. Data used were from the Mater-University of Queensland Study of Pregnancy, a community-based prospective birth cohort study begun in Brisbane, Australia, in 1981. Logistic regression analyses were conducted. Data were available for 5118 women. Women who experienced a higher burden of symptoms during pregnancy were at greater risk of becoming depressed and reporting poorer health status 14 years post partum. Women who experienced major problems during pregnancy were 4 times more likely to be depressed and nearly 8 times more likely to report poorer health status 14 years after the index pregnancy compared with women who experienced few problems. Findings suggest that pregnant women who experience common symptoms during pregnancy are likely to experience poorer mental and self-reported general health 14 years after the pregnancy.

Post-traumatic stress symptoms 5 years after military deployment to Afghanistan: an observational cohort study.

PubMed

Eekhout, Iris; Reijnen, Alieke; Vermetten, Eric; Geuze, Elbert

2016-01-01

Deployment can put soldiers at risk of developing post-traumatic stress symptoms. Despite several longitudinal studies, little is known about the timing of an increase in post-traumatic stress symptoms relative to pre-deployment. Longitudinal studies starting pre-deployment, in which participants are repeatedly measured over time, are warranted to assess the timing of an increase in symptoms to ultimately assess the timing of an increase in treatment demand after deployment. In this large observational cohort study, Dutch military personnel who were deployed to Afghanistan as part of the International Security Assistance Forces between March, 2005, and September, 2008, were assessed for post-traumatic stress symptoms with the Self-Rating Inventory for Post-traumatic Stress Disorder (SRIP) questionnaire. Participants were assessed 1 month before deployment and followed up at 1 month, 6 months, 12 months, 2 years, and 5 years after deployment, with changes in SRIP scores compared with pre-deployment using a mixed model analysis. The primary outcome was the total score of post-traumatic stress symptoms measured with SRIP at pre-deployment and the five follow-up assessments, with a score of 38 used as the cutoff to indicate substantial post-traumatic stress symptoms. Between March, 2005, and September, 2008, 1007 participants were recruited to this study. The results show two important effects of deployment on post-traumatic stress symptoms. A short-term symptom increase within the first 6 months after deployment (symptom increase coefficient for SRIP score vs pre-deployment [β] 0·99, 95% CI 0·50-1·48); and a long-term symptom increase at 5 years after deployment (β 1·67, 1·14-2·20). This study underlines the importance of long-term monitoring of the psychological health of soldiers after deployment because early detection of symptoms is essential to early treatment, which is related to improved psychological health. Dutch Ministry of Defense. Copyright © 2016

Post-Conflict Realities and the Future of Stability in Nepal

DTIC Science & Technology

2017-03-01

NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release. Distribution is unlimited. POST -CONFLICT REALITIES AND THE...DATE March 2017 3. REPORT TYPE AND DATES COVERED Master’s thesis 4. TITLE AND SUBTITLE POST -CONFLICT REALITIES AND THE FUTURE OF STABILITY IN... post -insurgency Nepal has failed to deliver on the promises of reform that brought it to power. The long-enduring social and economic grievances based

76 FR 20853 - Approval and Promulgation of Air Quality Implementation Plans; Kentucky; Approval of Section 110...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

... NAAQS through the year 2020 for the Four Kentucky Areas. These maintenance plans meet applicable... period of 10 years after redesignation, consistent with the CAA section 175A(a). EPA approved Kentucky's... attainment areas) were required to submit 10-year maintenance plans pursuant to section 110(a)(1) of the CAA...

Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

PubMed

DiMasi, Joseph A

2013-06-01

approval-phase time during the study period for applications that received a standard review rating from the FDA was substantially shorter for supplements compared to original uses, but the differences for applications that received a priority review rating from the FDA were negligible. Development of and regulatory approval for new uses of already-approved drugs and biologics is an important source of innovation by biopharmaceutical firms. Despite rising development costs, the output of new-use approvals has remained stable in recent years, driven largely by the pursuit of new pediatric indications. FDA approval-phase times have generally declined substantially for all types of applications since the mid-1990s following legislation that provided a new source of income for the agency. However, while the resources needed to review supplemental applications are likely lower in general than for original-use approvals, the approval-phase times for important new uses are no lower than for important original-use applications. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.

Deep Vadose Zone Treatability Test for the Hanford Central Plateau. Interim Post-Desiccation Monitoring Results, Fiscal Year 2015

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

Truex, Michael J.; Strickland, Christopher E.; Oostrom, Martinus

A field test of desiccation is being conducted as an element of the Deep Vadose Zone Treatability Test Program. The active desiccation portion of the test has been completed. Monitoring data have been collected at the field test site during the post-desiccation period and are reported herein. This is an interim data summary report that includes about 4 years of post-desiccation monitoring data. The DOE field test plan proscribes a total of 5 years of post-desiccation monitoring.

28 CFR 512.17 - Monitoring approved research projects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Monitoring approved research projects... MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.17 Monitoring approved research projects. The BRRB shall monitor all research projects for compliance with Bureau policies. At a minimum, yearly reviews...

28 CFR 512.17 - Monitoring approved research projects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Monitoring approved research projects... MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.17 Monitoring approved research projects. The BRRB shall monitor all research projects for compliance with Bureau policies. At a minimum, yearly reviews...

28 CFR 512.17 - Monitoring approved research projects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Monitoring approved research projects... MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.17 Monitoring approved research projects. The BRRB shall monitor all research projects for compliance with Bureau policies. At a minimum, yearly reviews...

A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study).

PubMed

Krucoff, Mitchell W; Rutledge, David R; Gruberg, Luis; Jonnavithula, Lalitha; Katopodis, John N; Lombardi, William; Mao, Vivian W; Sharma, Samin K; Simonton, Charles A; Tamboli, Hoshedar P; Wang, Jin; Wilburn, Olivia; Zhao, Weiying; Sudhir, Krishnankutty; Hermiller, James B

2011-12-01

The XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System Condition-of-Approval Post-Market study) sought to: 1) evaluate the safety of everolimus-eluting coronary stent systems (EECSS) in a contemporary cohort of real-world subjects; and 2) prospectively test the quality of event reporting with analysis of matched patients from the randomized SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions) trial. Randomized trials have demonstrated the safety and efficacy of EECSS in selected "standard-risk" patients. The XIENCE V USA trial was a prospective, multicenter, single-arm study in unselected patients. The primary endpoint was Academic Research Consortium (ARC)-defined definite and probable stent thrombosis (ST); the co-primary endpoint was the composite of cardiac death and myocardial infarction at 1 year. Secondary analyses included: 1) stratification by standard-risk and extended-risk cohorts; and 2) late ST after dual antiplatelet therapy interruption. Of 5,054 participants (1,875 standard-risk; 3,179 extended-risk), 4,958 (98.1%) reached 1-year follow-up. The rate of ARC-defined definite and probable ST was 0.84% (95% confidence interval [CI]: 0.60% to 1.14%) in the overall population and 0.33% (95% CI: 0.12% to 10.72%) and 1.14% (95% CI: 0.80% to 11.58%) in the standard-risk and extended-risk cohorts, respectively. No late ST was observed after dual antiplatelet therapy interruption in either cohort after 6 months. The composite rate of cardiac death and ARC-defined myocardial infarction was 6.5% (95% CI: 5.79% to 17.17%) in the overall population, 3.8% (95% CI: 2.98% to 14.78%) in the standard-risk cohort, and 8.0% (95% CI: 7.09% to 19.02%) in the extended-risk cohort. This study comprehensively reports ST rates for EECSS in a contemporary real-world population. The absence of ST after dual antiplatelet therapy interruption beyond 6 months in

75 FR 54419 - Notice: Elimination of Expiration Dates for Classification Approvals

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

.... PHMSA-2010-0245; Notice No. 10-6] Notice: Elimination of Expiration Dates for Classification Approvals... 2005, PHMSA initiated a policy imposing a 5-year expiration date on firework classification approvals... include all types of classification approvals, including explosives, oxidizing substances, organic...

The characteristics and fulfillment of conditional prescription drug approvals in Canada.

PubMed

Law, Michael R

2014-06-01

In order to more quickly approve drugs for rare and serious conditions, many countries have developed approval pathways that require companies to fulfill conditions after marketing. This analysis assessed the use and outcomes of Canada's Notice of Compliance with Conditions (NOC/c) program. Two publicly available databases from Health Canada were used to study the characteristics of the drugs approved using a NOC/c. Further, Kaplan-Meier analysis was used to estimate the median time-to-fulfillment for approval conditions. Seventy NOC/c approvals have been made, most commonly for cancer treatments. The conditions of the approvals were only publicly available for 24 of these approvals (34%). Approval conditions were fulfilled for 29 approvals (41%), remained outstanding for 34 (49%), had been revoked for 7 (10%). The median time to the fulfillment of conditions was about five years (1828 days; 95%CI: 1222-2325). Canadians have limited information on why conditional approvals are granted. As drugs are typically marketed for 5 years before conditions are met, better information should be provided to clinicians and patients so they can better understand treatment options. Further, steps to speed the fulfillment of conditions, such as time-limited approvals and the capability to levy financial penalties, should be added to the NOC/c regime. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Permanence and diffusion of borax-copper hydroxide remedial preservative applied to unseasoned pine posts : 10 year update

Treesearch

Douglas Crawford; Stan Lebow; Mike West; Bill Abbott

2005-01-01

In 1993, unseasoned pine posts were treated with groundline remedial treatment containing 3.1% copper hydroxide and 40% sodium tetraborate decahydrate (borax). The soundness of the posts was periodically evaluated using a push test. After 3.5, 6.5, and 10 years, sections were taken from two posts to determine retention of borax and copper hydroxide below ground to 36...

7 CFR 1717.608 - RUS approval of contracts.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Power supply arrangements. (1) Power supply contracts (including but not limited to economy energy sales... agreements, pooling agreements, and any other similar power supply arrangements subject to approval by RUS are deemed approved if they have a term of 2 years or less. Amendments to said power supply...

[Approval of ISO/IEC 17025 and quality control of laboratory testing].

PubMed

Yamamoto, Shigeki; Asakura, Hiroshi; Machii, Kenji; Igimi, Shizunobu

2010-01-01

First section of Division of Biomedical Food Research, National Institute of Health Sciences (NIHS) was approved by ISO/IEC 17025 as a laboratory having an appropriate laboratory testing technique. NIHS is the first national laboratory approved by ISO/IEC 17025. NIHS has also been accepted the appropriate technique and facility for the BSL3 level pathogens by ISO/IEC 17025. NIHS is necessary to take an external audit almost every year. This approval is renewed every 4 years.

7 CFR 4274.332 - Post award requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., justifies different amounts, a reserve for bad debts of 6 percent of outstanding loans must be accumulated... Program (IRP) § 4274.332 Post award requirements. (a) Applicability. Intermediaries receiving loans under this program shall be governed by these regulations, the loan agreement, the approved work plan...

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

PubMed

Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

2018-02-01

Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue

At the Crossroads: The Impact of New Irish Science Curricula on First Year Post-Primary Students

ERIC Educational Resources Information Center

Varley, Janet Penelope; Murphy, Cliona; Veale, Orlaith

2013-01-01

In Ireland, new science curricula were introduced at primary and early post-primary levels in 2003, in an effort to reverse declining interest and enrolment in science. This paper reports on a national study that explored first year post-primary students' experiences of and attitudes towards school science under these new curricula. Data were…

Predictors of post-traumatic psychological growth in the late years after lung transplantation.

PubMed

Fox, Kristen R; Posluszny, Donna M; DiMartini, Andrea F; DeVito Dabbs, Annette J; Rosenberger, Emily M; Zomak, Rachelle A; Bermudez, Christian; Dew, Mary Amanda

2014-04-01

Although lung transplantation improves quality of life, most psychosocial research focuses on adverse psychological and social functioning outcomes. Positive effects, particularly in the late-term years as physical morbidities increase, have received little attention. We provide the first data on a psychological benefit - post-traumatic growth (PTG) - and we focused on long-term (>5 yr) survivors. Among 178 patients from a prospective study of mental health during the first two yr post-transplant, we recontacted survivors 6-11 yr post-transplant. We assessed PTG (i.e., positive psychological change resulting from the transplant) and examined its relationship to other patient characteristics with multivariable regression analyses. Sixty-four patients (86% of survivors) were assessed (M = 8.1 yr post-transplant, SD = 1.2). Mean PTG exceeded the scale's midpoint (M = 38.6, SD = 10.0; scale midpoint = 25). Recipients experiencing greater PTG were female (p = 0.022), less educated (p = 0.014), and had a history of post-transplant panic disorder (p = 0.005), greater friend support (p = 0.048), and better perceived health (p = 0.032). Neither other pre- or post-transplant mood and anxiety disorders nor transplant-related morbidities (acute rejection, bronchiolitis obliterans syndrome) predicted PTG. PTG exceeded levels observed in other chronic disease populations, suggesting that lung transplantation may uniquely foster positive psychological change in long-term survivors. PTG occurs despite physical and psychiatric morbidities. Whether PTG promotes other positive post-transplant psychosocial outcomes deserves attention. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

42 CFR 84.30 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.30 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.30 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.30 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

42 CFR 84.30 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

Anti-HIV drugs: 25 compounds approved within 25 years after the discovery of HIV.

PubMed

De Clercq, Erik

2009-04-01

In 2008, 25 years after the human immunodeficiency virus (HIV) was discovered as the then tentative aetiological agent of acquired immune deficiency syndrome (AIDS), exactly 25 anti-HIV compounds have been formally approved for clinical use in the treatment of AIDS. These compounds fall into six categories: nucleoside reverse transcriptase inhibitors (NRTIs: zidovudine, didanosine, zalcitabine, stavudine, lamivudine, abacavir and emtricitabine); nucleotide reverse transcriptase inhibitors (NtRTIs: tenofovir); non-nucleoside reverse transcriptase inhibitors (NNRTIs: nevirapine, delavirdine, efavirenz and etravirine); protease inhibitors (PIs: saquinavir, ritonavir, indinavir, nelfinavir, amprenavir, lopinavir, atazanavir, fosamprenavir, tipranavir and darunavir); cell entry inhibitors [fusion inhibitors (FIs: enfuvirtide) and co-receptor inhibitors (CRIs: maraviroc)]; and integrase inhibitors (INIs: raltegravir). These compounds should be used in drug combination regimens to achieve the highest possible benefit, tolerability and compliance and to diminish the risk of resistance development.

49 CFR 451.13 - Action by approval authority-approval by design type.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

49 CFR 451.13 - Action by approval authority-approval by design type.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

49 CFR 451.13 - Action by approval authority-approval by design type.

Code of Federal Regulations, 2012 CFR

2012-10-01

...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

49 CFR 451.13 - Action by approval authority-approval by design type.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

49 CFR 451.13 - Action by approval authority-approval by design type.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

Post-stroke fatigue and return to work: a 2-year follow-up.

PubMed

Andersen, G; Christensen, D; Kirkevold, M; Johnsen, S P

2012-04-01

Post-stroke fatigue may affect the ability to return to work but quantitative studies are lacking. We included 83 first-ever stroke patients <60 years and employed either full-time (n = 77) or part-time (n = 6) at baseline. The patients were recruited from stroke units at Aarhus University Hospital between 2003 and 2005 and were followed for 2 years. Fatigue was assessed by the Multidimensional Fatigue Inventory. Pathological fatigue was defined as a score ≥12 on the General Fatigue dimension. Return to paid work was defined as working at least 10 h per week. Data were analyzed using multivariable logistic regression. A total of 58% of patients had returned to paid work after 2 years. The adjusted Odds Ratio (OR) for returning to paid work was 0.39 (95% confidence interval (CI) 0.16-1.08) for patients with a General Fatigue score ≥12 at baseline. Persisting pathological fatigue after 2 years of follow-up was associated with a lower chance of returning to paid work [adjusted OR 0.29 (95% CI 0.11-0.74)]. Higher scores of General Fatigue at follow-up also correlated negatively with the chance of returning to paid work when analyzing fatigue on a continuous scale (adjusted OR 0.87, 95% CI 0.80-0.94 for each point increase in General Fatigue). Post-stroke fatigue appears to be an independent determinant of not being able to resume paid work following stroke. © 2011 John Wiley & Sons A/S.

45 CFR 1386.31 - State Plan submittal and approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... State Plan to significant comments and suggestions. A summary of the Council's response to State Plan.... (c) Failure to submit an approvable State plan or amendment prior to the Federal fiscal years for... eligible for Federal financial participation. (d) The Commissioner must approve any State plan or plan...

45 CFR 1386.31 - State Plan submittal and approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... State Plan to significant comments and suggestions. A summary of the Council's response to State Plan.... (c) Failure to submit an approvable State plan or amendment prior to the Federal fiscal years for... eligible for Federal financial participation. (d) The Commissioner must approve any State plan or plan...

45 CFR 1386.31 - State Plan submittal and approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... State Plan to significant comments and suggestions. A summary of the Council's response to State Plan.... (c) Failure to submit an approvable State plan or amendment prior to the Federal fiscal years for... eligible for Federal financial participation. (d) The Commissioner must approve any State plan or plan...

45 CFR 1386.31 - State Plan submittal and approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... State Plan to significant comments and suggestions. A summary of the Council's response to State Plan.... (c) Failure to submit an approvable State plan or amendment prior to the Federal fiscal years for... eligible for Federal financial participation. (d) The Commissioner must approve any State plan or plan...

45 CFR 1386.31 - State Plan submittal and approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... State Plan to significant comments and suggestions. A summary of the Council's response to State Plan.... (c) Failure to submit an approvable State plan or amendment prior to the Federal fiscal years for... eligible for Federal financial participation. (d) The Commissioner must approve any State plan or plan...

The First Year of the Food and Drug Administration Oncology Center of Excellence: Landmark Approvals in a Dynamic Regulatory Environment.

PubMed

Goldberg, Kirsten B; Blumenthal, Gideon M; Pazdur, Richard

The Food and Drug Administration formally established the Oncology Center of Excellence (OCE) in January 2017, as authorized by the 21st Century Cures Act, to expedite the development and review of certain drugs, biologics, and devices for the treatment of cancer. In its first year, the OCE conducted the clinical reviews for several products, including the first 2 chimeric antigen receptor T-cell therapies approved for the treatment of advanced hematologic malignancies and an in vitro diagnostic next-generation sequencing panel, FoundationOne CDx. The OCE also worked with professional societies and patient advocates on efforts to modernize clinical trial eligibility criteria, resulting in recommendations regarding minimal age, brain metastases, organ dysfunction, and human immunodeficiency virus coinfection. Altogether in 2017, the Food and Drug Administration approved 16 new drug and biologic applications, 30 supplemental drug and biologic applications, and 2 biosimilar applications in oncology.

Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.

PubMed

Khozin, Sean; Abernethy, Amy P; Nussbaum, Nathan C; Zhi, Jizu; Curtis, Melissa D; Tucker, Melisa; Lee, Shannon E; Light, David E; Gossai, Anala; Sorg, Rachael A; Torres, Aracelis Z; Patel, Payal; Blumenthal, Gideon Michael; Pazdur, Richard

2018-03-01

Evidence from cancer clinical trials can be difficult to generalize to real-world patient populations, but can be complemented by real-world evidence to optimize personalization of care. Further, real-world usage patterns of programmed cell death protein 1 (PD-1) inhibitors following approval can inform future studies of subpopulations underrepresented in clinical trials. We performed a multicenter analysis using electronic health record data collected during routine care of patients treated in community cancer care clinics in the Flatiron Health network. Real-world metastatic non-small cell lung cancer (NSCLC) patients who received nivolumab or pembrolizumab in the metastatic setting ( n  = 1,344) were selected from a starting random sample of 55,969 NSCLC patients with two or more documented visits from January 1, 2011, through March 31, 2016. The primary study outcome measurement was demographic and treatment characteristics of the cohort. Median age at PD-1 inhibitor initiation was 69 years (interquartile range 61-75). Patients were 56% male, 88% smokers, 65% nonsquamous histology, and 64% diagnosed at stage IV. Of 1,344 patients, 112 (8%) were tested for programmed death-ligand 1 expression. Overall, 50% received nivolumab or pembrolizumab in the second line, with a substantial proportion of third and later line use that began to decline in Q4 2015. During the year following U.S. regulatory approval of PD-1 inhibitors for treatment of NSCLC, real-world patients receiving nivolumab or pembrolizumab were older at treatment initiation and more had smoking history relative to clinical trial cohorts. Studies of outcomes in underrepresented subgroups are needed to inform real-world treatment decisions. Evidence gathered in conventional clinical trials used to assess safety and efficacy of new therapies is not necessarily generalizable to real-world patients receiving these drugs following regulatory approval. Real-world evidence derived from electronic health

Trends in global approvals of biotech crops (1992-2014).

PubMed

Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

2015-01-01

With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.

Post-fire saguaro community: impacts on associated vegetation still apparent 10 years later

Treesearch

Marcia Narog; Ruth Wilson

2005-01-01

Fire impacts on saguaro (Carnegiea gigantea) associated vegetation were studied in unburned and burned areas over a 10 year post-fire period after the 1993 Vista View fire, Tonto National Forest, Arizona. Many associated species, crucial for saguaro survival, regenerate by vegetative growth after fire. Bushes were the most common nearest-neighbor,...

MECHANICAL TECHNOLOGY, DESIGN AND PRODUCTION, A SUGGESTED 2-YEAR POST HIGH SCHOOL CURRICULUM.

ERIC Educational Resources Information Center

Office of Education (DHEW), Washington, DC.

THE PURPOSE OF THIS CURRICULUM GUIDE IS TO ASSIST ADMINISTRATORS, SUPERVISORS, AND TEACHERS TO PLAN AND DEVELOP 2-YEAR POST-SECONDARY EDUCATION PROGRAMS IN MECHANICAL DESIGN AND PRODUCTION. TECHNICAL MATERIALS WERE DEVELOPED BY AN INSTITUTE STAFF FOR THE WISCONSIN STATE BOARD FOR VOCATIONAL EDUCATION UNDER CONTRACT TO THE U.S. OFFICE OF EDUCATION…

46 CFR 160.040-5 - Approval and production tests.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

46 CFR 160.040-5 - Approval and production tests.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

46 CFR 160.040-5 - Approval and production tests.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

46 CFR 160.040-5 - Approval and production tests.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

46 CFR 160.040-5 - Approval and production tests.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Rocket Type (and Equipment) § 160.040-5 Approval and production tests. (a) Approval tests. An independent... lot of rockets which fails the inspections and tests must not be represented as meeting this subpart... rockets at least once each year. The inspection must determine that the appliances and rockets are being...

Post-recurrence survival of elderly patients 75 years of age or older with surgically resected non-small cell lung cancer.

PubMed

Takenaka, Tomoyoshi; Inamasu, Eiko; Yoshida, Tsukihisa; Toyokawa, Gouji; Nosaki, Kaname; Hirai, Fumihiko; Yamaguchi, Masafumi; Seto, Takashi; Takenoyama, Mitsuhiro; Ichinose, Yukito

2016-04-01

The purpose of this study was to evaluate the outcomes of elderly patients 75 years of age or older with recurrent non-small cell lung cancer (NSCLC). A total of 1237 consecutive patients with NSCLC underwent pulmonary resection at our institution. Of these patients, 280 experienced postoperative recurrence. The rate of the post-recurrence survival and predictors were analyzed independently in a group of younger patients (<75 years) and a group of elderly patients (≥75 years). There were 215 younger patients (<75 years) and 65 elderly (≥75 years) patients at the time of diagnosis of recurrence. The median post-recurrence survival time and the five-year survival rate of all cases were 25 months and 20.8%, respectively. There were no significant survival differences between the younger and elderly groups (p = 0.20). A univariate analysis determined that gender, Eastern Cooperative Oncology Group performance status, smoking status, histological type and epithelial growth factor receptor (EGFR) mutation status were factors influencing the post-recurrence survival among the elderly patients. In addition, a multivariate analysis determined the EGFR mutation status to be an independent prognostic factor for the post-recurrence survival. Elderly patients 75 years of age or older in this study achieved satisfactory long-term outcomes.

TSO C-129 approvals and anticipated approvals

DOT National Transportation Integrated Search

2001-01-01

This document contains a table of the approvals and anticipated approvals of TSO-C129a equipment (the technical standard order (TSO) for Airborne Supplemental Navigation Equipment Using the Global Positioning System (GPS)). This TSO prescribes the mi...

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

PubMed

Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

2018-05-02

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Drug approval processes in Australian Paediatric Hospitals.

PubMed

Sinha, Y K; Craig, J C; Barclay, P; Taitz, J; South, M; Coulthard, K; Pearson, C; Erickson, S; Brien, J E

2010-09-01

To describe and evaluate the decision-making processes for drug approval in Australian paediatric hospitals. Multicentre descriptive study involving face-to-face interviews of drug and therapeutics committee chairs and secretaries, review of committee documents and drug submissions for all Australian paediatric hospital drug and therapeutics committees over a 1-year period. All eight paediatric hospitals in Australia. Eight committee chairs and seven secretaries or delegates. Total drug expenditure, number of formulary submissions, individual-patient use approvals and approval rates for each hospital from 1 July 2006 to 30 June 2007, stratified by therapeutic class. Qualitative description of the approval processes. Total drug expenditure varied from $A1.7 million (US$1.5 million) to $A11.1 million (US$9.8 million) per hospital. The number of formulary submissions also varied, from 7 to 21, but approval rate was high (76%-100%) and not significantly different among hospitals (p=0.17). Several committees approved identical submissions for five drugs. The number of individual-patient use applications varied considerably, ranging from 10 to 456 per hospital. Where estimable, individual-patient use approval was 76%-100% and variable (p=0.03). Quality of evidence relating to safety and efficacy of drugs being considered was regarded as the most important factors influencing decision making, with the cost less important. Most committees had poor infrastructural support for approval processes. No committee formally included a pharmaco-economic evaluation. Most drug submissions in tertiary paediatric hospitals are approved; however, workload, drug expenditure and individual-patient use schemes vary considerably. Duplication of effort occurs, and few committees are resourced sufficiently given their terms of reference.

Mental health consequences of weight cycling in the first-year post-treatment for breast cancer.

PubMed

Pila, Eva; Sabiston, Catherine M; Castonguay, Andrée L; Arbour-Nicitopoulos, Kelly; Taylor, Valerie H

2018-08-01

Weight cycling is linked with advanced breast cancer diagnosis, increased risk of cancer reoccurrence and cancer-related mortality. While women treated for breast cancer report challenges with navigating their post-treatment body shape and weight, the effects of weight cycling on body image and mental health have not been elucidated. This study examined associations between weight changes and weight cycling on psychological health (i.e. weight-related guilt, shame and depressive symptoms) among women in the first-year post-treatment. Self-reported assessments of pre-cancer weight cycling, post-treatment weight-related guilt, shame and depressive symptoms, and objective assessments of weight were assessed in a longitudinal sample of 173 women treated for breast cancer (M age  = 55.01 ± 10.96 years). Based on findings from multilevel models, women experienced the most weight-related shame when their weight was heavier than their personal average. Additionally, heavier weight was associated with worse psychological health, particularly for women with a history of stable (vs. cycling) weight pre-cancer. Weight cycling pre-cancer and post-treatment weight change have important implications for psychological well-being. Due to the potential psychological consequences associated with a history of weight cycling, targeted strategies are needed to improve overall health outcomes for women's survivorship after breast cancer.

Two-year post-discharge costs of care among patients treated with transcatheter or surgical aortic valve replacement in Germany.

PubMed

Kaier, Klaus; von Kampen, Frederike; Baumbach, Hardy; von Zur Mühlen, Constantin; Hehn, Philip; Vach, Werner; Zehender, Manfred; Bode, Christoph; Reinöhl, Jochen

2017-07-11

This study presents data on post-discharge costs of care among patients treated with transcatheter or surgical aortic valve replacement over a two year period. Based on a prospective clinical trial, post-discharge utilization of health services and status of assistance were collected for 151 elderly patients via 2250 monthly telephone interviews, valued using standardized unit costs and analysed using two-part regression models. At month 1 post-discharge, total costs of care are substantially elevated (monthly mean: €3506.7) and then remain relatively stable over the following 23 months (monthly mean: €622.3). As expected, the majority of these costs are related to in-hospital care (~98% in month 1 post-discharge and ~72% in months 2-24). Patients that died during follow-up were associated with substantially higher cost estimates of in-hospital care than those surviving the two-year study period, while patients' age and other patient characteristics were of minor relevance. Estimated costs of outpatient care are lower at month 1 than during the rest of the study period, and not affected by the event of death during follow-up. The estimated costs of nursing care are, in contrast, much higher in year 2 than in year 1 and differ substantially by gender and type of procedure as well as by patients' age. Overall, these monthly cost estimates add up to €10,352 for the first and €7467.6 for the second year post-discharge. Substantial cost increases at month 1 post-discharge and in case of death during follow-up are the main findings of the study, which should be taken into account in future economic evaluations on the topic. Application of standardized unit costs in combination with monthly patient interviews allows for a far more precise estimate of the variability in post-discharge health service utilization in this group of patients than the ones given in previous studies. German Clinical Trial Register Nr. DRKS00000797 .

A 12-year follow-up study of combined treatment of post-severe acute respiratory syndrome patients with femoral head necrosis.

PubMed

Liu, Tiansheng; Ma, Jinchao; Su, Bin; Wang, Hao; Wang, Qi; Ma, Xinlong

2017-01-01

To investigate the long-term efficacy of a combination treatment of alendronate, extracorporeal shock and hyperbaric oxygen for osteonecrosis of the femoral head (ONFH) of post-severe acute respiratory syndrome (SARS) patients. The retrospective study was performed including a total of 37 post-SARS ONFH patients (66 hip joints) in the Department of Orthopedics of the General Hospital of Tianjin Medical University between November 2003 and November 2015, consisting of 6 males (11 hip joints) and 31 females (55 hip joints), with age between 19 and 47 years (average 29.9 years). Visual analog scale (VAS) score, Harris score and Association Research Circulation Osseous (ARCO) stage of imaging examination were compared among those before treatment, and at 1, 3, 6, 9 and 12 years after treatment. Paired t -test was used for statistical analysis of VAS and Harris score before and after treatment. Difference of effective rate on all stages was analyzed with Chi-square test. With 12-year follow-up, significant improvements on VAS (6.81 of pre-treatment vs 3.94 of 12-year post-treatment) and Harris score (74.54 of pre-treatment vs 80.14 of 12-year post-treatment) were observed (all p <0.05). Effective rate showed statistical significance among three stages of ARCO ( p <0.05). The combined treatment showed different efficacies on different ARCO stages; the best was on ARCO Phase I. The combined treatment may delay or discontinue the development of ONFH in post-SARS patients.

77 FR 11677 - Medicaid Program; Review and Approval Process for Section 1115 Demonstrations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... experimental, pilot, and demonstration projects approved under section 1115 of the Social Security Act relating... selected provisions of section 1902 of the Act for experimental, pilot, or demonstration projects... application, and recommended that CMS allow the State to not post a complete application. The commenters noted...

Predicting early post-partum depressive symptoms among older primiparous Japanese mothers.

PubMed

Iwata, Hiroko; Mori, Emi; Tsuchiya, Miyako; Sakajo, Akiko; Maehara, Kunie; Ozawa, Harumi; Morita, Akiko; Maekawa, Tomoko; Aoki, Kyoko; Makaya, Miyuki; Tamakoshi, Koji

2015-10-01

The number of older primiparas is increasing in Japan. These women have been shown to be more vulnerable to post-partum depression. This study aimed to identify factors for predicting post-partum depressive symptoms during hospitalization after childbirth in Japanese primiparas aged 35 years and over. The present authors used the data of 479 primiparas aged 35 years and over from a prospective cohort study. Data were collected using self-report questionnaires on the day before hospital discharge. The questionnaire consisted of: demographics and background information; depressive symptoms; fatigue; maternal confidence and maternal satisfaction; child-care values; physical symptoms; perceptions of daily life during hospitalization; concerns about child care and daily life; and infant feeding. Additionally, vital records data were obtained from the hospitals. A stepwise logistic regression analysis was performed on the binary outcome variable of depressive symptoms, measured by the Japanese version of the Edinburgh Postnatal Depression Scale. Women who scored 9 or more were considered to be at high risk for post-partum depression. The authors obtained informed consent from all participants and institutional ethics approvals before initiating the study. The following six variables reliably predicted the risk of post-partum depression: emergency cesarean section, lower satisfaction with birth experience, higher physical burden in daily life, long-term complications with the newborn, more concerns about newborn caretaking after discharge, and more concerns about one's own life after discharge. Recognition of women with these factors will help nurses to identify those at risk for developing post-partum depression and to provide appropriate care during hospitalization after childbirth. © 2015 The Authors. Japan Journal of Nursing Science © 2015 Japan Academy of Nursing Science.

Clinicopathological Spectrum of Endometrial Changes in Peri-menopausal and Post-menopausal Abnormal Uterine Bleeding: A 2 Years Study.

PubMed

Damle, Rajshri P; Dravid, N V; Suryawanshi, Kishor H; Gadre, Arundhati S; Bagale, Priya S; Ahire, Neelam

2013-12-01

Abnormal uterine bleeding is the Common presenting complaint in Gynaecology Outpatient Department in all age groups. It is due to the anovulatory cycles which are commonly seen in adolescent and peri-menopausal women. Abnormal uterine bleeding is caused by wide variety of organic or non-organic causes. Histopathological examination of endometrial sample remains the gold standard for diagnosis of endometrial pathology. To study the clinicopathological spectrum of endometrium in abnormal uterine bleeding in peri-menopausal and post-menopausal age groups. The study included prospective analysis of 119 cases of endometrial samples in patients of abnormal uterine bleeding above 40 years of age. The specimens were routinely processed and H&E stained slides were studied. Patients were categorized into peri-menopausal (40-49 years) and post-menopausal (> 50 years) age group. A total of 119 specimens of endometrium were analyzed. Maximum number (73.94%) of cases were from peri-menopausal age group. The most common presenting complaint was menorrhagia (48.86%) followed by post-menopausal bleeding (26.05%). In peri-menopausal age group proliferative endometrium (35.22%) was the predominant histopathological pattern followed by endometrial hyperplasia (23.86%). Atrophic endometrium (25.80%) was the most frequent finding followed by endometrial hyperplasia (19.35%) in post-menopausal age group. Three cases of endometrial carcinoma were reported in post-menopausal age group only. A thorough histopathological work up and clinical correlation is mandatory in cases of abnormal uterine bleeding above the age of 40 years to find out organic lesions. Careful screening can detect early cancer of endometrium which has excellent prognosis and it will help in further management.

Tonopah Test Range Post-Closure Inspection Annual Report, Tonopah Test Range, Nevada, Calendar Year 2003

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

U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office; Bechtel Nevada

This post-closure inspection report provides documentation of the semiannual inspection activities, maintenance and repair activities, and conclusions and recommendations for calendar year 2003 for eight corrective action units located on the Tonopah Test Range, Nevada.

Multimethod psychoeducational intervention for preschool children with disruptive behavior: two-year post-treatment follow-up.

PubMed

Shelton, T L; Barkley, R A; Crosswait, C; Moorehouse, M; Fletcher, K; Barrett, S; Jenkins, L; Metevia, L

2000-06-01

This paper describes the 2-year post-treatment follow-up of preschool children identified as having high levels of disruptive behavior at kindergarten entry. They were assigned to four treatment conditions: A no-treatment group, parent-training only, treatment classroom only, and the combination of parent training with the treatment classroom. Interventions lasted the entire kindergarten academic year. Initial post-treatment results reported previously indicated no effects for the parent-training program but some efficacy for the classroom intervention program. For this report, the disruptive behavior (DB) children were subdivided into those who did (n = 74) and did not (n = 77) receive the treatment classroom. Two-year post-treatment follow-up results indicated no differences between the classroom treated and untreated DB groups. These groups also failed to differ in the percentage of children using available treatments across the follow-up period. The DB children in both groups had significantly more symptoms of ADHD and ODD than a community control group (N = 47) at follow-up. They also received higher ratings of externalizing problems on the parent Child Behavior Checklist, more severe ratings of behavior problems at home, and ratings of more pervasive behavior problems at school, and had poorer academic skills. Results suggested that early intervention classrooms for DB children may not produce enduring effects once treatment is withdrawn, and that better approaches are needed for identifying those DB children at greatest risk for later maladjustment.

30 CFR 28.20 - Certificates of approval; scope of approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Certificates of approval; scope of approval. 28.20 Section 28.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT...

Trends in global approvals of biotech crops (1992–2014)

PubMed Central

Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

2015-01-01

ABSTRACT With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992–2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits. PMID:26039675

75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-24

... of the availability of safety and effectiveness summaries of approved PMAs through the Internet and... New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 301-796- 6570. SUPPLEMENTARY... and denials in the Federal Register. Instead, the agency now posts this information on the Internet on...

75 FR 54154 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

... effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management... and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650... Federal Register. Instead, the agency now posts this information on the Internet on FDA's home page at...

75 FR 72829 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-26

... and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... Federal Register. Instead, the Agency now posts this information on the Internet on FDA's home page at...

30 CFR 746.14 - Approval, disapproval or conditional approval, of mining plan.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., of mining plan. 746.14 Section 746.14 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR FEDERAL LANDS PROGRAM REVIEW AND APPROVAL OF MINING PLANS § 746.14 Approval, disapproval or conditional approval, of mining plan. The Secretary shall approve, disapprove or...

Objective Assessment of Changes in Physical Activity and Sedentary Behavior: Pre-through 3-Years Post- Bariatric Surgery

PubMed Central

King, Wendy C; Chen, Jia-Yuh; Bond, Dale S; Belle, Steven H; Courcoulas, Anita P; Patterson, Emma J; Mitchell, James E; Inabnet, William B; Dakin, George F; Flum, David R; Cook, Brian; Wolfe, Bruce M

2015-01-01

Objective To evaluate change in sedentary behavior (SB) and physical activity (PA) over three years following bariatric surgery. Methods A subset of participants in an observational study (n=473 of 2458; 79% female, median body mass index 45kg/m2) wore an activity monitor pre-surgery and at 1–3 annual post-surgery assessments. Results Over the first year, on average, sedentary time decreased from 573 (95%CI 563–582) to 545 (95%CI 534–555) min/d and moderate-to-vigorous intensity PA (MVPA) increased from 77 (95%CI: 71–84) to 106 (95%CI: 98–116) min/wk, or 7 (95%CI: 5–10) to 24 (95%CI: 18–29) min/wk in MVPA bouts ≥10 minutes. There were no changes in these parameters from years 1 to 3 (P for all>.05). The percentage of participants achieving ≥150 min/wk of bout-related MVPA was not different at year 3 [6.5% (95%CI: 3.1–12.7)] vs. pre-surgery [3.4% (95%CI: 1.8–5.0); p=.45]. Most participants followed SB and PA trajectories that paralleled mean change and were consistent with their pre-surgery position in relation to the group. Conclusions On average, bariatric surgical patients make small reductions in SB and increases in PA during the first post-surgery year, which are maintained through 3 years. Still, post-surgery PA levels fall short of PA guidelines for general health or weight control. PMID:26010326

77 FR 1873 - Approval and Promulgation of Implementation Plans; Georgia; Rome; Fine Particulate Matter 2002...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-12

...] Approval and Promulgation of Implementation Plans; Georgia; Rome; Fine Particulate Matter 2002 Base Year... is taking direct final action to approve the fine particulate matter (PM 2.5 ) 2002 base year... progress (RFP) plan, contingency measures, a 2002 base year emissions inventory and other planning SIP...

77 FR 12487 - Approval and Promulgation of Implementation Plans; Georgia; Atlanta; Fine Particulate Matter 2002...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

...] Approval and Promulgation of Implementation Plans; Georgia; Atlanta; Fine Particulate Matter 2002 Base Year... is taking direct final action to approve the fine particulate matter (PM 2.5 ) 2002 base year... progress (RFP) plan, contingency measures, a 2002 base year emissions inventory and other planning SIP...

77 FR 12724 - Approval and Promulgation of Implementation Plans; Georgia; Macon; Fine Particulate Matter 2002...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-02

...] Approval and Promulgation of Implementation Plans; Georgia; Macon; Fine Particulate Matter 2002 Base Year... is taking direct final action to approve the fine particulate matter (PM 2.5 ) 2002 base year... progress (RFP) plan, contingency measures, a 2002 base year emissions inventory and other planning SIP...

Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board.

PubMed

Zia, Mohammad I; Heslegrave, Ronald; Newton, Gary E

2011-12-01

The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.

29 CFR 1903.2 - Posting of notice; availability of the Act, regulations and applicable standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... has an approved poster informing employees of their protections and obligations as defined in § 1952.10 of this chapter, such poster, when posted by employers covered by the State plan, shall constitute...) Reproductions or facsimiles of such Federal or State posters shall constitute compliance with the posting...

29 CFR 1903.2 - Posting of notice; availability of the Act, regulations and applicable standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... has an approved poster informing employees of their protections and obligations as defined in § 1952.10 of this chapter, such poster, when posted by employers covered by the State plan, shall constitute...) Reproductions or facsimiles of such Federal or State posters shall constitute compliance with the posting...

29 CFR 1903.2 - Posting of notice; availability of the Act, regulations and applicable standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... has an approved poster informing employees of their protections and obligations as defined in § 1952.10 of this chapter, such poster, when posted by employers covered by the State plan, shall constitute...) Reproductions or facsimiles of such Federal or State posters shall constitute compliance with the posting...

29 CFR 1903.2 - Posting of notice; availability of the Act, regulations and applicable standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... has an approved poster informing employees of their protections and obligations as defined in § 1952.10 of this chapter, such poster, when posted by employers covered by the State plan, shall constitute...) Reproductions or facsimiles of such Federal or State posters shall constitute compliance with the posting...

29 CFR 1903.2 - Posting of notice; availability of the Act, regulations and applicable standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... has an approved poster informing employees of their protections and obligations as defined in § 1952.10 of this chapter, such poster, when posted by employers covered by the State plan, shall constitute...) Reproductions or facsimiles of such Federal or State posters shall constitute compliance with the posting...

Commission on Teacher Credentialing Approves 8 ELL-Related Credential Options

ERIC Educational Resources Information Center

Frost, Jeff; Cadiero-Kaplan, Karen; Kuhlman, Natalie

2011-01-01

On September 30, 2010, the California Commission on Teacher Credentialing (CTC) voted unanimously to approve a set of eight recommendations for authorization to teach English language learners. These recommendations approved by the CTC had been in development for almost two years and they focused on several issues, including: (1) a specific focus…

Diversion and injection of buprenorphine-naloxone film two years post-introduction in Australia.

PubMed

Larance, Briony; Mattick, Richard; Ali, Robert; Lintzeris, Nicholas; Jenkinson, Rebecca; White, Nancy; Kihas, Ivana; Cassidy, Rosemary; Degenhardt, Louisa

2016-01-01

We report 2 years of post-marketing surveillance of the diversion and injection of buprenorphine-naloxone (BNX) film following its introduction in 2011. Interviews were conducted with people who inject drugs regularly (PWID) (2004-2013), opioid substitution therapy clients (2013, n = 492) and key experts (n = 44). Key outcomes were unsanctioned removal of supervised doses, diversion, injection and street price. Prevalence of past 6-month injection among PWID was adjusted for background availability of opioid substitution therapy medications using sales data. Among out-of-treatment PWID, the levels of regular (weekly+) BNX film injection were comparable to methadone and BNX tablets, and lower than mono-buprenorphine, adjusting for background availability. Fewer BNX film clients [3%; 95% (CI) 1-5] regularly injected their medication than mono-buprenorphine clients (25%; 95% CI 11-39), but at levels equivalent to those among methadone (3%; 95% CI 1-6) and BNX tablet clients (2%; 95% CI 0-6). Key experts perceived BNX film needed less supervised dosing time as it dissolved rapidly and was harder to remove from the mouth than sublingual tablets; however, removal of supervised doses was higher among BNX film clients (15%; 95% CI: 10-20) than methadone clients (3%; 95% CI 1-6), and not significantly different from BNX tablet (11%; 95% CI 2-21) and mono-buprenorphine clients (31%; 95% CI 16-46). Two years post-introduction, levels of BNX film diversion and injection remained comparable with those for methadone and BNX tablets, and lower than mono-buprenorphine. We found no evidence that BNX film has lower non-adherence and diversion than the tablet formulation. [Larance B, Mattick R, Ali R, Lintzeris N, Jenkinson R, White N, Kihas I, Cassidy R, Degenhardt L. Diversion and injection of buprenorphine-naloxone film two years post-introduction in Australia. Drug Alcohol Rev 2015]. © 2015 Australasian Professional Society on Alcohol and other Drugs.

Research Ethics Education in Post-Graduate Medical Curricula in I.R. Iran.

PubMed

Nikravanfard, Nazila; Khorasanizadeh, Faezeh; Zendehdel, Kazem

2017-08-01

Research ethics training during post-graduate education is necessary to improve ethical standards in the design and conduct of biomedical research. We studied quality and quantity of research ethics training in the curricula of post-graduate programs in the medical science in I.R. Iran. We evaluated curricula of 125 post-graduate programs in medical sciences in I.R. Iran. We qualitatively studied the curricula by education level, including the Master and PhD degrees and analyzed the contents and the amount of teaching allocated for ethics training in each curriculum. We found no research ethics training in 72 (58%) of the programs. Among the 53 (42%) programs that considered research ethics training, only 17 programs had specific courses for research ethics and eight of them had detailed topics on their courses. The research ethics training was optional in 25% and mandatory in 76% of the programs. Post-graduate studies that were approved in the more recent years had more attention to the research ethics training. Research ethics training was neglected in most of the medical post-graduate programs. We suggest including sufficient amount of mandatory research ethics training in Master and PhD programs in I.R. Iran. Further research about quality of research ethics training and implementation of curricula in the biomedical institutions is warranted. © 2016 John Wiley & Sons Ltd.

17 CFR 40.3 - Voluntary submission of new products for Commission review and approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... FUTURES TRADING COMMISSION PROVISIONS COMMON TO REGISTERED ENTITIES § 40.3 Voluntary submission of new...) Describe any agreements or contracts entered into with other parties that enable the registered entity to...) Certify that the registered entity posted a notice of its request for Commission approval of the new...

17 CFR 40.3 - Voluntary submission of new products for Commission review and approval.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FUTURES TRADING COMMISSION PROVISIONS COMMON TO REGISTERED ENTITIES § 40.3 Voluntary submission of new...) Describe any agreements or contracts entered into with other parties that enable the registered entity to...) Certify that the registered entity posted a notice of its request for Commission approval of the new...

17 CFR 40.3 - Voluntary submission of new products for Commission review and approval.

Code of Federal Regulations, 2014 CFR

2014-04-01

... FUTURES TRADING COMMISSION PROVISIONS COMMON TO REGISTERED ENTITIES § 40.3 Voluntary submission of new...) Describe any agreements or contracts entered into with other parties that enable the registered entity to...) Certify that the registered entity posted a notice of its request for Commission approval of the new...

Post-traumatic stress symptoms, parenting stress and mother-child relationships following childbirth and at 2 years postpartum.

PubMed

McDonald, Sarah; Slade, Pauline; Spiby, Helen; Iles, Jane

2011-09-01

This study examined the prevalence of childbirth-related post-traumatic stress (PTS) symptoms at 2 years postpartum and the relationship between such symptoms and both self-reported parenting stress and perceptions of the mother-child relationship. 81 women completed measures of childbirth-related PTS symptoms at 6 weeks and 3 months postpartum; these results were used in an exploration of their predictive links with mother-child relationship and parenting measures at 2 years. 17.3% of respondents reported some PTS symptoms at a clinically significant level at 2 years postpartum. However, these symptoms were only weakly linked to parenting stress and were not related to mothers' perceptions of their children. However earlier PTS symptoms within 3 months of childbirth did show limited associations with parenting stress at 2 years but no association with child relationship outcomes once current depression was taken into account. Implications for clinical practice and the concept of childbirth-related post-traumatic stress disorder are discussed.

Post-fire response of coast redwood one year after the Mendocino lightning complex fires

Treesearch

Robert B. Douglas; Tom. Bendurel

2012-01-01

Coast redwood (Sequoia sempervirens) forests have undergone significant changes over the past century and are now in state more conducive for wildfires. Because fires have been uncommon in redwood forests over the past 80 years, managers have limited data to make decisions about the post-fire environment. In June 2008, a series of lightning storms...

77 FR 59156 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; The Washington County...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-26

... Promulgation of Air Quality Implementation Plans; Maryland; The Washington County 2002 Base Year Inventory... approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the State of... proposing to approve the 2002 base year PM 2.5 emissions inventory for Washington County submitted by MDE in...

Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

PubMed

Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

2011-10-01

Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

Design and analysis of post-marketing research.

PubMed

Zhou, Xiao-Hua Andrew; Yang, Wei

2013-07-01

A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

A Model to Predict Psychological- and Health-Related Adjustment in Men with Prostate Cancer: The Role of Post Traumatic Growth, Physical Post Traumatic Growth, Resilience and Mindfulness.

PubMed

Walsh, Deirdre M J; Morrison, Todd G; Conway, Ronan J; Rogers, Eamonn; Sullivan, Francis J; Groarke, AnnMarie

2018-01-01

Background: Post traumatic growth (PTG) can be defined as positive change following a traumatic event. The current conceptualization of PTG encompasses five main dimensions, however, there is no dimension which accounts for the distinct effect of a physical trauma on PTG. The purpose of the present research was to test the role of PTG, physical post traumatic growth (PPTG), resilience and mindfulness in predicting psychological and health related adjustment. Method: Ethical approval was obtained from relevant institutional ethics committees. Participants ( N = 241), who were at least 1 year post prostate cancer treatment, were invited to complete a battery of questionnaires either through an online survey or a paper and pencil package received in the post The sample ranged in age from 44 to 88 years ( M = 64.02, SD = 7.76). Data were analysis using confirmatory factor analysis and structural equation modeling. Results: The physical post traumatic growth inventory (P-PTGI) was used to evaluate the role of PPTG in predicting adjustment using structural equation modeling. P-PTGI predicted lower distress and improvement of quality of life, whereas conversely, the traditional PTG measure was linked with poor adjustment. The relationship between resilience and adjustment was found to be mediated by P-PTGI. Conclusion: Findings suggest the central role of PTG in the prostate cancer survivorship experience is enhanced by the inclusion of PPTG. Adjusting to a physical trauma such as illness (internal transgressor) is unlike a trauma with an external transgressor as the physical trauma creates an entirely different framework for adjustment. The current study demonstrates the impact of PPTG on adjustment. This significantly adds to the theory of the development of PTG by highlighting the interplay of resilience with PTG, PPTG, and adjustment.

77 FR 50446 - Approval and Promulgation of Implementation Plans; Tennessee; Knoxville; Fine Particulate Matter...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-21

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2010-0153(b); FRL-9717-4] Approval and Promulgation of Implementation Plans; Tennessee; Knoxville; Fine Particulate Matter 2002 Base Year Emissions... approve the 1997 annual fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of...

38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

Code of Federal Regulations, 2010 CFR

2010-07-01

... approvals of community residential care facilities. 17.65 Section 17.65 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Community Residential Care § 17.65 Approvals and provisional approvals of community residential care facilities. (a) An approval of a facility meeting all of...

75 FR 60711 - Request for Extension and Revision of a Currently Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-01

... of Management and Budget (OMB) approve a 3-year extension of a currently approved information... States Grain Standards Act and under the Agricultural Marketing Act of 1946.'' This approval is required... in the above office during regular business hours (7 CFR 1.27(b)). Please call the Management and...

Race and Sex Differences in Post-Myocardial Infarction Angina Frequency and Risk of 1-Year Unplanned Rehospitalization.

PubMed

Hess, Connie N; Kaltenbach, Lisa A; Doll, Jacob A; Cohen, David J; Peterson, Eric D; Wang, Tracy Y

2017-02-07

Race and sex disparities in in-hospital treatment and outcomes of patients with acute myocardial infarction (MI) have been described, but little is known about race and sex differences in post-MI angina and long-term risk of unplanned rehospitalization. We examined race and sex differences in post-MI angina frequency and 1-year unplanned rehospitalization to identify factors associated with unplanned rehospitalization, testing for whether race and sex modify these relationships. Using TRANSLATE-ACS (Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome) data, we examined 6-week and 1-year angina frequency and 1-year unplanned rehospitalization stratified by race and sex among MI patients treated with percutaneous coronary intervention. We used multivariable logistic regression to assess factors associated with unplanned rehospitalization and tested for interactions among angina frequency, race, and sex. A total of 11 595 MI patients survived to 1 year postdischarge; there were 66.6% white male patients, 24.3% white female patients, 5.3% black male patients, and 3.8% black female patients. Overall, 29.7% had angina at 6 weeks, and 20.6% had angina at 1 year postdischarge. Relative to white patients, black patients were more likely to have angina at 6 weeks (female: 44.2% versus 31.8%; male: 33.5% versus 27.1%; both P<0.0001) and 1 year (female: 49.4% versus 38.9%; male: 46.3% versus 31.1%; both P<0.0001). Rates of 1-year unplanned rehospitalization were highest among black female patients (44.1%), followed by white female patients (38.4%), black male patients (36.4%), and white male patients (30.2%, P<0.0001). In the multivariable model, 6-week angina was most strongly associated with unplanned rehospitalization (hazard ratio, 1.49; 95% confidence interval, 1.36-1.62; P<0.0001); this relationship was not modified by race or sex (adjusted 3-way P interaction =0.41). One

Avelumab: First Global Approval.

PubMed

Kim, Esther S

2017-05-01

Avelumab (Bavencio ® ) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.

Year 5 Post-Remediation Biomonitoring of Pesticides and other Contaminants in Marine Waters near the United Heckathorn Superfund Site, Richmond, California

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

Kohn, Nancy P.; Kropp, Roy K.

Marine sediment remediation at the United Heckathorn Superfund Site in Richmond, California, was completed in April 1997. The Record of Decision included a requirement for five years of post-remediation monitoring be conducted in the waterways near the site. The present monitoring year, 2001? 2002, is the fifth and possibly final year of post-remediation monitoring. In March 2002, water and mussel tissues were collected from the four stations in and near Lauritzen Channel that have been routinely monitored since 1997-98. A fifth station in Parr Canal was sampled in Year 5 to document post-remediation water and tissue concentrations there. Dieldrin andmore » dichlorodiphenyl trichloroethane (DDT) were analyzed in water samples and in tissue samples from resident (i.e., naturally occurring) mussels. As in Years 3 and 4, mussels were not transplanted to the study area in Year 5. Year 5 concentrations of dieldrin and total DDT in water and total DDT in tissue were compared with those from Years 1 through 4 of post-remediation monitoring, and with preremediation data from the California State Mussel Watch Program and the Ecological Risk Assessment for the United Heckathorn Superfund Site. Year 5 water samples and mussel tissues were also analyzed for polychlorinated biphenyls (PCB), which were detected in sediment samples during Year 2 monitoring and were added to the water and mussel tissue analyses in 1999. Contaminants of concern in Year 5 water samples were analyzed in both bulk (total) phase and dissolved phase, as were total suspended solids, to evaluate the contribution of particulates to the total contaminant concentration.« less

New Evaluation System Wins Approval

ERIC Educational Resources Information Center

Barrett, Laura

2011-01-01

All Massachusetts school districts will have to adopt new evaluation systems based on a state framework that was approved by the Board of Elementary and Secondary Education on June 28. The new system will be phased in over three years, beginning with Level 4 schools--those designated "underperforming" by the state--in the 2011-12 school…

42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2012-10-01 2012-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2011-10-01 2011-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2013-10-01 2013-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Approval. Centers that have lost their Medicare approval may seek re-entry into the Medicare program at any... 42 Public Health 5 2010-10-01 2010-10-01 false Special procedures for approval and re-approval of... ENFORCEMENT PROCEDURES Special Requirements § 488.61 Special procedures for approval and re-approval of organ...

76 FR 9281 - Approval and Promulgation of Air Quality Implementation Plans; Massachusetts; Revised Carbon...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-17

... Massachusetts. This SIP submittal contains revisions to the carbon monoxide (CO) maintenance plan for Lowell... plan. The intended effect of this action is to propose approval of this revision to the Lowell CO..., 5 Post Office Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912. 5. Hand Delivery or...

22 CFR 96.51 - Post-adoption services in incoming cases.

Code of Federal Regulations, 2013 CFR

2013-04-01

... the agency's or person's responsibilities. (c) When post-adoption reports are required by the child's... Accreditation and Approval Standards for Cases in Which A Child Is Immigrating to the United States (incoming... measures to ensure that the transfer of the child takes place in secure and appropriate circumstances, with...

22 CFR 96.51 - Post-adoption services in incoming cases.

Code of Federal Regulations, 2012 CFR

2012-04-01

... the agency's or person's responsibilities. (c) When post-adoption reports are required by the child's... Accreditation and Approval Standards for Cases in Which A Child Is Immigrating to the United States (incoming... measures to ensure that the transfer of the child takes place in secure and appropriate circumstances, with...

22 CFR 96.51 - Post-adoption services in incoming cases.

Code of Federal Regulations, 2014 CFR

2014-04-01

... the agency's or person's responsibilities. (c) When post-adoption reports are required by the child's... Accreditation and Approval Standards for Cases in Which A Child Is Immigrating to the United States (incoming... measures to ensure that the transfer of the child takes place in secure and appropriate circumstances, with...

22 CFR 96.51 - Post-adoption services in incoming cases.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the agency's or person's responsibilities. (c) When post-adoption reports are required by the child's... Accreditation and Approval Standards for Cases in Which A Child Is Immigrating to the United States (incoming... measures to ensure that the transfer of the child takes place in secure and appropriate circumstances, with...

22 CFR 96.51 - Post-adoption services in incoming cases.

Code of Federal Regulations, 2011 CFR

2011-04-01

... the agency's or person's responsibilities. (c) When post-adoption reports are required by the child's... Accreditation and Approval Standards for Cases in Which A Child Is Immigrating to the United States (incoming... measures to ensure that the transfer of the child takes place in secure and appropriate circumstances, with...

Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.

PubMed

Mattingly, T Joseph; Simoni-Wastila, Linda

2017-10-01

Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential. Although the gold standard for establishing safety and efficacy through randomized controlled trials has been in place for more than 50 years, it poses several limitations for rare disorders where patient recruitment for traditional clinical trials is a major barrier. Organized efforts by patient advocacy groups to help patients with rare diseases access investigational therapy have had a legislative and regulatory effect. After approval by the FDA, patient access to therapy may still be limited by cost. A managed care organization (MCO) with the fiduciary responsibility of managing the health of a population must weigh coverage decisions for costly therapies with questionable effectiveness against alternatives within the constraint of a finite budget. Even when the FDA deems a drug safe and effective, an MCO may determine that the drug should only be made available at a tier level where out-of-pocket costs are still too high for many patients. This limitation of availability may be due to cost, other treatment alternatives, or outcomes from existing clinical evidence. However, if the MCO makes a costly new treatment for a rare disease readily available, it may temporarily satisfy a small contingency at the cost of all of its members. This article examines the risks and benefits of patient-centered drug approval and the potential economic effect of patient-centered drug approval on population health. There is no funding to disclose. Mattingly

Survival in advanced diffuse large B-cell lymphoma in pre- and post-rituximab Eras in the United States.

PubMed

Shah, Binay Kumar; Bista, Amir; Shafii, Bahman

2014-09-01

Rituximab was approved by the United States Food and Drug Administration (FDA) as a first-line agent for treatment of advanced diffuse large B-cell lymphoma (DLBCL) in February 2006. We conducted this population-based study to determine if the results from the clinical trials have translated into survival benefit in the general population. We selected patients with advanced diffuse large B-cell lymphoma from the Surveillance, Epidemiology, and End RESULTS (SEER) 18 database, and calculated relative survival rates for patients diagnosed from 2002-2005 (pre-rituximab) and 2006-2009 (post-rituximab). We used the Z-test in the SEER*Stat to compare relative survival rates of patients categorized by race (White, Black, or Others), gender (male, female), and age groups (<60, 60+ years). One-year relative survival in Whites and Others improved significantly in the post-rituximab era compared to the pre-rituximab era (64.80±0.6% vs. 61.3±0.6%; p=0.0002 and 64.5±1.9% vs. 54.9±2.2%; p=0.0011, respectively). The 3-year relative survival improved significantly in Whites and Others in the post-rituximab era compared to the pre-rituximab era (53.7±0.7% vs. 50.3±0.7%; p=0.0001 and 52.0±2.3% vs. 40.8±2.3%; p=0.0002, respectively). However, no significant improvements were observed in 1-year and 3-year relative survival in Blacks, and in young males during the post-rituximab era compared to the pre-rituximab era. The relative survival rates among young males and 'Black' patients with advanced diffuse large B-cell lymphoma have not improved during the post-rituximab era. Copyright© 2014 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

Continuity of drunk and drugged driving behaviors four years post-college.

PubMed

Caldeira, Kimberly M; Arria, Amelia M; Allen, Hannah K; Bugbee, Brittany A; Vincent, Kathryn B; O'Grady, Kevin E

2017-11-01

Driving under the influence of alcohol is a leading cause of injury and premature death among young adults, and college-educated individuals are at particularly high risk. Less is known about driving under the influence of other drugs, which is on the rise. This study describes prospective seven-year trends in alcohol and other drug (AOD)-involved driving among a young-adult sample beginning with their second year of college (i.e., Years 2-8), and documents the extent of continuity in such behaviors across time. Originally recruited as incoming first-year students at one large public university, participants (n=1194) were interviewed annually about how frequently they drove while drunk/intoxicated (DWI), after drinking any alcohol (DAD), and/or while under the influence of other drugs (DD). Follow-up rates were high (>75% annually). Among participants with access to drive a car, annual prevalence peaked in Year 4 (modal age 21) for both DWI (24.3% wt ) and DD (19.1% wt ) and declined significantly thereafter through Year 8 (both ps<0.05). DAD was far more prevalent than DWI or DD, increasing from 40.5% wt in Year 2 to 66.9% wt in Year 5, and plateauing thereafter. Among marijuana-using participants, likelihood of DD was consistently greater than the likelihood of DWI among Heavy Episodic and Light-to-Moderate drinkers, and it declined significantly during Years 5-8 (p<0.05). Post-college declines in heavy drinking and DWI prevalence were encouraging but did not necessarily translate to reductions in likelihood of engaging in DWI, depending on drinking pattern. College-educated individuals represent an important target for AOD-involved driving prevention. Copyright © 2017 Elsevier B.V. All rights reserved.

Post-transplant increased levels of serum sCD30 is a marker for prediction of kidney allograft loss in a 5-year prospective study.

PubMed

Delgado, Julio C; Pavlov, Igor Y; Shihab, Fuad S

2009-12-01

Levels of sCD30 represent a biomarker for early outcome in kidney transplantation. The purpose of this study was to determine the role of sCD30 levels for prediction of graft loss in the late post-transplant period. Sera were collected immediately pre-transplant and yearly thereafter for up to 5-year post-transplant in 37 primary renal transplant recipients. Levels of serum sCD30 were tested using a fluorescent microsphere assay. Levels of sCD30 significantly decreased after transplantation and remained normal in 34 patients without graft loss up to 5-year post-transplant. Elevated levels of serum sCD30 preceded the increase of serum creatinine in patients with subsequent graft loss. Elevated levels of serum sCD30 post-transplant might be a marker for predicting subsequent graft loss in the post-transplant period.

19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

Code of Federal Regulations, 2011 CFR

2011-04-01

... OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115... 19 Customs Duties 1 2011-04-01 2011-04-01 false Certificate of approval for containers approved...

19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

Code of Federal Regulations, 2010 CFR

2010-04-01

... OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115... 19 Customs Duties 1 2010-04-01 2010-04-01 false Certificate of approval for containers approved...

19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

Code of Federal Regulations, 2012 CFR

2012-04-01

... OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115... 19 Customs Duties 1 2012-04-01 2012-04-01 false Certificate of approval for containers approved...

19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

Code of Federal Regulations, 2014 CFR

2014-04-01

... OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115... 19 Customs Duties 1 2014-04-01 2014-04-01 false Certificate of approval for containers approved...

19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

Code of Federal Regulations, 2013 CFR

2013-04-01

... OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARGO CONTAINER AND ROAD VEHICLE CERTIFICATION PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115... 19 Customs Duties 1 2013-04-01 2013-04-01 false Certificate of approval for containers approved...

77 FR 12769 - Approval and Promulgation of Implementation Plans; Georgia; Macon; Fine Particulate Matter 2002...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-02

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2011-0850-201154(b); FRL-9639-7] Approval and Promulgation of Implementation Plans; Georgia; Macon; Fine Particulate Matter 2002 Base Year... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory, portion of...

77 FR 12526 - Approval and Promulgation of Implementation Plans; Georgia; Atlanta; Fine Particulate Matter 2002...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2012-0050-201207(b); FRL-9639-3] Approval and Promulgation of Implementation Plans; Georgia; Atlanta; Fine Particulate Matter 2002 Base Year... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory, portion of...

78 FR 17282 - Agency Information Collection Activities; Approval of a Currently Approved Information Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... Research and Information Technology and Chief Information Officer. [FR Doc. 2013-06361 Filed 3-19-13; 8:45...-0379] Agency Information Collection Activities; Approval of a Currently Approved Information Collection... March 1, 2013, concerning request for comments on the approval of a currently approved information...

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.

PubMed

Davis, Courtney; Naci, Huseyin; Gurpinar, Evrim; Poplavska, Elita; Pinto, Ashlyn; Aggarwal, Ajay

2017-10-04

Objective  To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe. Design  Retrospective cohort study. Setting  Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013. Main outcome measures  Pivotal and postmarketing trials of cancer drugs according to their design features (randomisation, crossover, blinding), comparators, and endpoints. Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry. Validated European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) used to assess the clinical value of the reported gains in published studies of cancer drugs. Results  From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%). Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation, in the subsequent postmarketing period there was evidence for extension of life in three (7%) and reported benefit on quality of life in five (11%). Of the 68 cancer indications with EMA approval, and with a median of 5.4 years' follow-up (minimum 3.3 years, maximum 8.1 years), only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain. Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (11/23, 48%). Conclusions

Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

PubMed

Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

2015-01-01

Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations.

PubMed

Hey, Spencer Phillips; Kesselheim, Aaron S

2017-03-01

Many hold that the so-called golden era of antibiotic discovery has passed, leaving only a limited clinical pipeline for new antibiotics. A logical conclusion of such arguments is that we need to reform the current system of antibiotic drug research-including clinical trials and regulatory requirements-to spur activity in discovery and development. The United States Congress in the past few years has debated a number of bills to address this crisis, including the 2012 Generating Antibiotic Incentives Now Act and the 2016 21st Century Cures Act. Experts have also sought to advance antibiotic development by encouraging greater use of trials with noninferiority hypotheses, which are thought to be easier to conduct. The goal underlying these proposals is to stave off the post-antibiotic era by expanding the pharmaceutical armamentarium as quickly as possible. But although new antibiotic agents are necessary to combat the long-term threat of drug-resistant disease, we argue that these research policies, which effectively lower the bar for antibiotic approval, are ethically problematic. Rather, given broader public health considerations related to the full lifecycle of antibiotic use-including development of resistance-we should reject an overly permissive approach to new antibiotic approval and instead set the bar for regulatory approval at a point that will naturally direct research resources toward the most transformative chemical or social interventions. © 2017 The Hastings Center.

7 CFR 932.19 - Crop year and fiscal year.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Regulating Handling Definitions § 932.19 Crop year and fiscal year. (a) Crop year means the 12-month period... be recommended by the committee and approved by the Secretary. (b) Fiscal year means the 12-month... 7 Agriculture 8 2010-01-01 2010-01-01 false Crop year and fiscal year. 932.19 Section 932.19...

Relationship between functional disability and costs one and two years post stroke

PubMed Central

Lekander, Ingrid; Willers, Carl; von Euler, Mia; Lilja, Mikael; Sunnerhagen, Katharina S.; Pessah-Rasmussen, Hélène; Borgström, Fredrik

2017-01-01

Background and purpose Stroke affects mortality, functional ability, quality of life and incurs costs. The primary objective of this study was to estimate the costs of stroke care in Sweden by level of disability and stroke type (ischemic (IS) or hemorrhagic stroke (ICH)). Method Resource use during first and second year following a stroke was estimated based on a research database containing linked data from several registries. Costs were estimated for the acute and post-acute management of stroke, including direct (health care consumption and municipal services) and indirect (productivity losses) costs. Resources and costs were estimated per stroke type and functional disability categorised by Modified Rankin Scale (mRS). Results The results indicated that the average costs per patient following a stroke were 350,000SEK/€37,000–480,000SEK/€50,000, dependent on stroke type and whether it was the first or second year post stroke. Large variations were identified between different subgroups of functional disability and stroke type, ranging from annual costs of 100,000SEK/€10,000–1,100,000SEK/€120,000 per patient, with higher costs for patients with ICH compared to IS and increasing costs with more severe functional disability. Conclusion Functional outcome is a major determinant on costs of stroke care. The stroke type associated with worse outcome (ICH) was also consistently associated to higher costs. Measures to improve function are not only important to individual patients and their family but may also decrease the societal burden of stroke. PMID:28384164

Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study.

PubMed

Hermiller, James B; Rutledge, David R; Mao, Vivian W; Zhao, Weiying; Wang, Jin; Gruberg, Luis; Lombardi, William; Sharma, Samin K; Krucoff, Mitchell W

2014-07-01

The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions. Patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events. Improved safety and efficacy of XIENCE V everolimus eluting stents (EES) have been previously demonstrated in selected low-risk small vessel populations in randomized clinical trials. The XIENCE V USA study was a condition of approval, single-arm study in unselected real-world patients. Baseline and 1-year clinical outcomes were compared between XIENCE V USA patients who received a single 2.5 mm stent (small vessel group, N = 838) and patients implanted with a single >2.5 mm stent (non-small vessel group, N = 2,015). Mean reference vessel diameter was 2.55 ± 0.36 and 3.25 ± 0.46 mm in the small and non-small vessel groups, respectively (P < 0.001). Small vessel group had more females, presented with a higher rate of diabetes, and had more complex lesion characteristics. The definite or probable ST rates analyzed using Kaplan-Meier method were low and not significantly different between the groups at 0.37 and 0.40% for the small and nonsmall vessel group (P = 0.88), respectively. The composite rate of cardiac death or MI was comparable at 4.5% for the small and 5.1% for the non-small vessel 1 groups (P = 0.57). The 1-year target lesion revascularization rate was also comparable in the small vessel group (3.8% vs. 3.0%, P = 0.35). Despite gender difference, higher prevalence of diabetes and more complex lesions in the small vessel groups, the 1-year clinical outcomes were similar in both small and nonsmall vessel groups. These results demonstrate the therapeutic benefit of XIENCE V EES in a real-world all inclusive patient population with small vessel disease. © 2013 Wiley Periodicals, Inc.

Influence of site and operator characteristics on carotid artery stent outcomes: analysis of the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) clinical study.

PubMed

Gray, William A; Rosenfield, Kenneth A; Jaff, Michael R; Chaturvedi, Seemant; Peng, Lei; Verta, Patrick

2011-02-01

The aim of this study was to analyze the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) study for physician- or site-related variables associated with differential outcomes for carotid artery stenting (CAS). The CAPTURE 2 trial is an ongoing, prospective, nonrandomized, independently adjudicated, multicenter clinical study enrolling high-surgical-risk patients undergoing CAS. In this assessment of the CAPTURE 2 study, the American Heart Association carotid endarterectomy guideline limits were used to define acceptable site and physician CAS outcomes; therefore, the resulting population of nonoctogenarian, asymptomatic subjects in this analysis is confined to 3,388 (of the total 5,297) subjects treated at 180 U.S. hospitals by 459 operators between March 2006 and January 2009. The rates of death, stroke, and myocardial infarction and death and stroke (DS) at 30 days were 3.5% and 3.3%, respectively, for the full CAPTURE 2 study cohort and 2.9% and 2.7%, respectively, for the asymptomatic, nonoctogenarian subgroup. In this subgroup, two-thirds of sites (118 of 180, 66%) had no DS events. Within the remaining sites, an inverse relationship between event rates and hospital patient volume as well as between event rates and individual operator volume was observed. The DS rates trended lower for interventional cardiologists compared with other specialties. Outcomes from the largest prospectively gathered, independently adjudicated, multicenter CAS study indicate that CAS can be safely performed in a variety of hospital settings by physicians with various specialties. The most important determinant of perioperative CAS outcomes was both site and operator CAS volume. A threshold of 72 cases was found to be necessary for consistently achieving a DS rate below 3% in this later-phase single arm study; background era and non-study operator experience will affect this determination. (Second Phase of "Carotid RX ACCULINK/RX ACCUNET Post-Approval

Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support).

PubMed

Jorde, Ulrich P; Kushwaha, Sudhir S; Tatooles, Antone J; Naka, Yoshifumi; Bhat, Geetha; Long, James W; Horstmanshof, Douglas A; Kormos, Robert L; Teuteberg, Jeffrey J; Slaughter, Mark S; Birks, Emma J; Farrar, David J; Park, Soon J

2014-05-06

A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial. New device technology developed in the clinical research setting requires validation in a real-world setting. The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry. Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group. Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7

Depressive, anxiety and post-traumatic stress disorders at six years after occupational injuries.

PubMed

Chin, Wei-Shan; Shiao, Judith Shu-Chu; Liao, Shih-Cheng; Kuo, Chun-Ya; Chen, Chih-Chieh; Guo, Yue Leon

2017-09-01

The aim of this study is to determine the prevalence rates of depressive, anxiety and PTSDs, and the risk factors for psychological symptoms at 6 years after occupational injury. This longitudinal study followed workers who were occupationally injured in 2009. Psychological symptoms and return to work were assessed at 3 and 12 months after injury. Injured workers who had completed the initial questionnaire survey at 3 or 12 months after injury were recruited. A self-administered questionnaire was mailed to the participants. For workers with high Brief Symptom Rating Scale and Post-traumatic Symptom Checklist scores, an in-depth psychiatric evaluation was performed using the Mini-international Neuropsychiatric Interview. A total of 570 workers completed the questionnaire (response rate, 28.7%). Among them, 243 (42.6%) had high psychological symptom scores and were invited for a phone interview; 135 (55.6%) completed the interview. The estimated rates of major depression and post-traumatic stress disorder (PTSD)/partial PTSD were 9.2 and 7.2%, respectively, and both these rates were higher at 6 years after injury than at 12 months after injury (2.0 and 5.1%). After adjustment for family and social factors, the risk factors for high psychological scores were length of hospitalization immediately after injury, affected physical appearance, repeated occupational injuries, unemployment, and number of quit jobs after the injury. At 6 years after occupational injury, the re-emergence of psychiatric disorders was observed. Relevant factors for poor psychological health were severity of injury and instability of work. Periodic monitoring of psychological and physical health and economic stability are warranted.

A Ten-Year Analysis of the Post-Secondary Outcomes of Students with Disabilities at the Pennsylvania State University

ERIC Educational Resources Information Center

Hong, Barbara S. S.; Herbert, James T.; Petrin, Robert A.

2011-01-01

This proposed exploratory study represents the largest and first investigation in the USA that will purposefully analyse and track students who have sought disability services over a 10-year span (academic years 2000-2011). Using "ex post-facto" data on a non-probability purposive sample of approximately 6000 undergraduates, the research…

9 CFR 130.11 - User fees for inspecting and approving import/export facilities and establishments.

Code of Federal Regulations, 2010 CFR

2010-01-01

... hourly user fee rate in § 130.30(2) applies to biosecurity level two laboratories. (b) [Reserved] [65 FR... approval) Per year $537.00 $553.00 $570.00 $587.00 $604.00 Inspection for approval of biosecurity level three labs (all inspections related to approving the laboratory for handling one defined set of...

78 FR 23544 - Proposed Extension of Approval of Information Collection; Comment Request: Recordkeeping...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-19

... Information Collection; Comment Request: Recordkeeping Requirements Under the Safety Standard for Infant...) requests comments on a proposed 3-year extension of approval of information collection for the... and Budget (OMB) previously approved the collection of information under control number 3041-0141. OMB...

46 CFR 169.849 - Posting placards containing instructions for launching and inflating inflatable liferafts.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Inspections § 169.849 Posting placards containing instructions for launching and inflating inflatable... accessible to the ship's company and guests approved placards containing instructions for launching and... determined by the Officer in Charge, Marine Inspection. ...

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

PubMed

Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

2018-01-01

Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

77 FR 65683 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-30

... Activities; Submission to OMB for Review and Approval; Comment Request; EPA's Design for the Environment (DfE... Budget (OMB) for review and approval: EPA's Design for the Environment (DfE) Partner of the Year Awards... . Title: EPA's Design for the Environment (DfE) Partner of the Year Awards Program. ICR Status: This is a...

Factors affecting graft survival within 1-year post-transplantation in heart and lung transplant: an analysis of the OPTN/UNOS registry.

PubMed

Ohe, Hidenori

2012-01-01

Today, a main focus of the transplant community is the long-term outcomes of lung and heart allograft recipients. However, even early post-transplant survival (within the first post-transplant year) needs improvement, as early graft failure still accounts for many allograft losses. In this chapter, we review the experience of heart and lung transplantation as reported to the Organ Procurement Transplant Network/United Network of Organ Sharing registry and investigate the factors responsible for causing failure in the first post-transplant year. Trends indicate that sicker patients are increasingly being transplanted, thereby limiting improvements in early post-transplant survival. More lung and heart transplant patients are coming to transplant on dialysis. In heart transplant, there is an increase in the number of heart retransplant patients and an increase in patients on extracorporeal membrane oxygenation. For lung transplant, more patients are on a ventilator prior to transplant than in the past 25 years. Given that sicker/riskier patients are now receiving more heart and lung transplants, future studies need to take place to better understand these patients so that they can have the same survival as patients entering transplant with less severe illnesses.

Research ethics board approval for an international thromboprophylaxis trial.

PubMed

Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

2012-06-01

Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

7 CFR 1944.415 - Grant approval and other approving authorities.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., DEPARTMENT OF AGRICULTURE (CONTINUED) PROGRAM REGULATIONS (CONTINUED) HOUSING Self-Help Technical Assistance... 7 Agriculture 13 2010-01-01 2009-01-01 true Grant approval and other approving authorities. 1944.415 Section 1944.415 Agriculture Regulations of the Department of Agriculture (Continued) RURAL...

The relationship between psychiatric morbidity and quality of life: interview study of Norwegian tsunami survivors 2 and 6 years post-disaster.

PubMed

Hussain, Ajmal; Nygaard, Egil; Siqveland, Johan; Heir, Trond

2016-05-31

The study investigated the impact of psychiatric disorders on Quality of Life (QOL) cross-sectionally and longitudinally in a group of Norwegian tourists severely exposed to the 2004 tsunami. Sixty-two adult Norwegian tsunami survivors were interviewed face to face 2 years post-tsunami (T1) and 58 were interviewed again by telephone 6 years post-tsunami (T2). The majority (81 %) reported direct exposure to the waves, and 14 participants (23 %) lost a close family member in the tsunami. Psychiatric morbidity was measured by structured clinical interviews and QOL was assessed with WHO's Quality of Life-Bref scale. Multiple linear regression analyses were performed to assess the independent effects of psychiatric disorders on QOL 2 and 6 years after the tsunami. Psychiatric disorders, especially depression, but also PTSD and other anxiety disorders, were associated with reduced QOL. Psychiatric disorders were more strongly related to QOL at 6 years after the tsunami than at 2 years. Psychiatric disorders, and especially depression, is related to reduced QOL in a disaster exposed population. Post-disaster psychiatric disorders, such as PTSD and especially depression, should be addressed properly in the aftermath of disasters.

Adolescent Perceptions of Maternal Approval of Birth Control and Sexual Risk Behavior.

ERIC Educational Resources Information Center

Jaccard, James; Dittus, Patricia J.

2000-01-01

Used data from the Longitudinal Study of Adolescent health to examine the relationship between adolescent perception of maternal approval of the use of birth control and sexual outcomes over 12 months. Overall, adolescents' perceptions of maternal approval related to an increased likelihood of sexual intercourse in the next year and an increase in…

Post-traumatic stress disorder and its predictors among bereaved Tibetan adolescents four years after the Yushu earthquake: a cross-sectional survey in China.

PubMed

Dongling, Liu; Hui, Chen; Ling, Ma; Wenqian, Bie; Zailiang, Liu; Changying, Chen

2017-04-01

To examine the prevalence of post-traumatic stress disorder symptoms and to explore the predictive factors of post-traumatic stress disorder symptoms among bereaved adolescents four years after the Yushu earthquake. On 14 April 2010, the 7·1-magnitude Yushu earthquake occurred in the high-altitude, hypoxia-prone regions primarily inhabited by ethnic minorities. Many adolescents lost their parents during the earthquake. This study examined post-traumatic stress disorder and its predictors among bereaved Tibetan adolescents four years after the trauma in China. This was a cross-sectional descriptive study. This study used a cross-sectional design with 830 bereaved adolescents. Participant demographic data included gender, age and grade, and the earthquake exposure variables included the deceased relatives, whether they were buried, injured or amputated (non-life-threatening) and whether they witnessed a burial, injury or death. The post-traumatic stress disorder Checklist-Civilian version was used to assess the symptoms and prevalence of post-traumatic stress disorder, and the Coping Style Scale assessed coping styles. The results indicated that the prevalence of post-traumatic stress disorder was 19·3%. Individuals who were buried, injured or amputated (non-life-threatening), who witnessed a burial, injury or death, who suffered severe property loss during the earthquake and who had negative coping skills were the most likely individuals to have post-traumatic stress disorder symptoms. The presence of post-traumatic stress disorder was very prevalent among adolescents four years after the Yushu earthquake. Effective mental health services should be developed to facilitate postdisaster recovery for bereaved adolescents at high risk for post-traumatic stress disorder. The findings in this study improve our understanding of post-traumatic stress disorder and related risk factors in bereaved adolescents in non-Western communities, providing useful information for

76 FR 52658 - State Program Requirements; Approval of Application for Program Revision to the National...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-23

... (ADEC) in four phases. Phases I-III have been transferred from the EPA to ADEC. In March 2011, ADEC made a submission for approval for a one year extension of the transfer of Phase IV of the APDES program... facilities not previously transferred in Phases I-III. The EPA approved the one year extension for Phase IV...

10 CFR 1016.8 - Approval for processing access permittees for security facility approval.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Approval for processing access permittees for security facility approval. 1016.8 Section 1016.8 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) SAFEGUARDING OF RESTRICTED DATA Physical Security § 1016.8 Approval for processing access permittees for security facility...

10 CFR 1016.8 - Approval for processing access permittees for security facility approval.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Approval for processing access permittees for security facility approval. 1016.8 Section 1016.8 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) SAFEGUARDING OF RESTRICTED DATA Physical Security § 1016.8 Approval for processing access permittees for security facility...

Punishments: What Predicts Adult Approval.

ERIC Educational Resources Information Center

Buntain-Ricklefs, Joanne J.; And Others

1994-01-01

A survey of 449 parents found that 24% experienced uncommon punishments (such as burning) during their childhoods and 6% approved; 45% experienced and 17% approved of common punishments (shaking); and 94% experienced and 88% approved of very common punishments (spanking). Approval of each punishment was related to experience. Race, income, and…

Redfield Energy Approval

EPA Pesticide Factsheets

This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

77 FR 2266 - Request for Extension and Revision of a Currently Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-17

... DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration Request for Extension and Revision of a Currently Approved Information Collection AGENCY: Grain Inspection, Packers and...- year extension and revision of a currently approved information collection for ``Export Inspection and...

Survival of teeth treated with cast post and cores: A retrospective analysis over an observation period of up to 19.5 years.

PubMed

Raedel, Michael; Fiedler, Cliff; Jacoby, Stephan; Boening, Klaus W

2015-07-01

Scientific data about the long-term survival of teeth treated with cast post and cores are scarce. Retrospective studies often use different target events for their analyses. A comparison is therefore complicated. For associated tooth-, jaw-, and patient-related factors little evidence exists as to their effect on survival. The purpose of this study was to extend the knowledge on the survival of teeth treated with cast post and cores for observation periods of more than 10 years. A decrease or increase in survival times according to the presence or absence of associated parameters needs to be evaluated. A retrospective evaluation was conducted of all cast post and cores inserted in 1 university clinic between January 1992 and June 2011. A Kaplan-Meier survival analysis was carried out by using extraction as the target event. The survival curves for different tooth types, the presence or absence of adjacent teeth, and the prosthetic restoration of the respective jaws were compared by using the log-rank test (α=.05). A Cox regression model was calculated for multivariate analyses. A total of 717 cast post and cores for 343 patients were recorded. The mean survival time was 13.5 years. A statistically significant decrease in survival times was found for canines (11.9 years) and premolars (13.4 years) versus molars (14.1 years), no adjacent teeth (10.6 years) versus at least 1 adjacent tooth (13.8 years), and the restoration with removable dental prostheses (12.5 years) versus fixed dental prostheses and single crowns (13.9 years). The largest reduction in survival time was found for teeth being used as an abutment for a double crown-retained removable partial dental prosthesis (telescopic denture) (9.8 years). Tooth type and adjacent tooth status remained as significant variables within the multivariate Cox regression model. Cast post and cores have an acceptable long-term survival time. Because different factors may influence survival, considering these factors in

At the Crossroads: The Impact of New Irish Science Curricula on First Year Post-Primary Students

NASA Astrophysics Data System (ADS)

Varley, Janet Penelope; Murphy, Clíona; Veale, Órlaith

2013-02-01

In Ireland, new science curricula were introduced at primary and early post-primary levels in 2003, in an effort to reverse declining interest and enrolment in science. This paper reports on a national study that explored first year post-primary students' experiences of and attitudes towards school science under these new curricula. Data were gathered from 366 pupils using survey and case study approaches. Findings revealed broadly positive attitudes towards post-primary school science, especially the experimental work that is at the heart of the new curriculum. However, it would appear that students were not conducting open-ended investigations or using information and communications technology [ICT] to any great extent; moreover, there was some evidence of traditional teaching methods being utilised. Pupils were highly critical of previous primary school science experiences, reporting a lack of `hands-on' activities, didactic methodologies and, for a significant minority, a paucity of any memorable primary science at all. Improvements in curricular implementation are proposed.

40 CFR 52.2425 - Base Year Emissions Inventory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 5 2013-07-01 2013-07-01 false Base Year Emissions Inventory. 52.2425... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virginia § 52.2425 Base Year Emissions Inventory. (a) EPA approves as a revision to the Virginia Implementation Plan the 1990 base year...

40 CFR 52.2425 - Base Year Emissions Inventory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 5 2012-07-01 2012-07-01 false Base Year Emissions Inventory. 52.2425... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virginia § 52.2425 Base Year Emissions Inventory. (a) EPA approves as a revision to the Virginia Implementation Plan the 1990 base year...

[The problem of post-marketing surveillance planning on drugs for infectious disease].

PubMed

Sato, J

2001-12-01

In principle, a new drug is approved via the assessments of safety and efficacy by the Ministry of Health, Labor and Welfare (MHLW). After approval, conduct of post-marketing surveillance is requested by law in order to assess the safety and efficacy of the drug in a large number of patients. Before initiating a surveillance, submission to MHLW of a document on the plan of survey is necessary in the purpose of inspection if it includes any ethical or regulatory problem or not. Through the inspections of the plans submitted during the period of April 1998 and March 2000, many problems have been pointed out. In this report, the author introduces some of the concrete problems noted in the plans on drugs for infectious diseases and shows some of the guidance made by the authority how to improve them. It is expected that such practical analyses of cases may be useful for future planning of post-marketing surveillance on drugs for infectious diseases.

Understanding young adult physical activity, alcohol and tobacco use in community colleges and 4-year post-secondary institutions: A cross-sectional analysis of epidemiological surveillance data

PubMed Central

2010-01-01

Background Young adults experience many adverse health behavior changes as they transition from adolescence into adulthood. A better understanding of the relationships between health promoting and risky health behaviors may aid in the development of health promotion interventions for various types of young adult post-secondary students. Therefore, the purpose of this study was to examine associations between alcohol and tobacco use and physical activity among 2-year and 4-year college students. Methods Cross-sectional analyses were conducted using 2007 survey data, collected as part of an on-going post-secondary health surveillance system in Minnesota. Students were randomly selected to participant from 14 Minnesota colleges and universities (six 2-year community and/or technical colleges, eight 4-year post-secondary institutions). The 2007 surveillance data included 9,931 respondents. Results The prevalence of demographic characteristics and health behaviors (e.g., physical activity, tobacco use) differed between young adults attending 2-year and 4-year post-secondary institutions; in general, those attending 2-year institutions are representative of more at-risk populations. Overall, higher levels of moderate, vigorous and strengthening physical activity were associated with higher levels of alcohol consumption and lower levels of smoking. In general, despite the disparities in the prevalence of these risk behaviors, the associations between the behaviors did not differ substantially between 2-year and 4-year post-secondary populations. Conclusions These findings illustrate links between leading risk behaviors. Interventions targeting multiple risk behaviors among young adults may warrant further consideration. Overall, future research is needed to support and inform young adult health promotion efforts that may be implemented in a wide array of post-secondary institutions. PMID:20420678

[Twenty-year History and Future Challenges in Transparency Enhancement of Review Process for Approval: Focus on Public Release of Review Reports regarding New Drugs and Medical Devices].

PubMed

Morimoto, Kazushige; Kawasaki, Satoko; Yoshida, Yasunori

2015-01-01

For 20 years, the Ministry of Health, Labour and Welfare (MHLW, formerly Ministry of Health and Welfare (MHW)) has been trying to increase transparency of the review process for approving reports in order to promote the rational use of newly approved drugs and medical devices. The first Summary Basis of Approval (SBA) was published by MHW in 1994. In 1999, evaluation reports were prepared by MHW and the Pharmaceuticals and Medical Devices Evaluation Center to make them available to the public. In 2005, a notice from the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) made procedures for public release of information on reviewing applications for new drugs. In 2006, 90 review reports of newly approved drugs and eight medical devices were revealed on PMDA websites. The dissemination of information by the United States Food and Drug Administration (FDA) and that of the European Medicines Agency (EMA) were studied and compared with that of the MHLW and PMDA. While common technical documents (CTD) for new drugs and summary technical documents (STED) for new medical devices have been released by PMDA, such documents are not released by the FDA and EMA. The European Public Assessment Report (EAPR) summary for the public is an interesting questionnaire approach that uses the "What," "How" and "Why" format. Finally, future proposals for the next decade are also outlined.

Jaw symptoms and signs and the connection to cranial cervical symptoms and post-traumatic stress during the first year after a whiplash trauma.

PubMed

Severinsson, Yvonne; Bunketorp, Olle; Wenneberg, Bengt

2010-01-01

To estimate the prevalence of jaw symptoms and signs during the first year after a neck sprain in a car collision. Further, to determine their relationships to the localisation and grade of the initial neck symptoms and signs, headache, post-traumatic stress and crash characteristics. One hundred and forty-six adult subjects and crash characteristics were prospectively investigated in an in-depth study during 1997-2001. Head, neck, and jaw symptoms and signs were recorded within 5 weeks and after 1 year. Acute post-traumatic stress was estimated with the Impact of Event Scale-Revised (IES-R). Jaw symptoms were initially reported by three men (5%) and three women (4%), and subsequently developed in eight women (10%) during the following year. Jaw signs were noted initially in 53 subjects (37%) and in 28 subjects (24%) after 1 year, without difference between sexes, and more often after low-speed impacts. Headache in females, cranial cervical symptoms, pronounced neck problems, post-traumatic stress and whiplash-associated disorders (WAD) grade II-III after rear-end impacts were related to jaw signs during the acute phase. After 1 year, jaw signs were related to residual neck problems, headache and post-traumatic stress. Jaw symptoms are seldom reported during the acute phase after a whiplash trauma. Women more often than men develop jaw symptoms during the first year. Jaw symptoms and signs may develop also after low-speed impacts, especially after rear-end collisions. Jaw symptoms and signs should be observed after whiplash trauma, especially in those with headache, pronounced neck problems, cranial neck symptoms and post-traumatic stress.

Approving cancer treatments based on endpoints other than overall survival: an analysis of historical data using the PACE Continuous Innovation Indicators™ (CII).

PubMed

Brooks, Neon; Campone, Mario; Paddock, Silvia; Shortenhaus, Scott; Grainger, David; Zummo, Jacqueline; Thomas, Samuel; Li, Rose

2017-01-01

There is an active debate about the role that endpoints other than overall survival (OS) should play in the drug approval process. Yet the term 'surrogate endpoint' implies that OS is the only critical metric for regulatory approval of cancer treatments. We systematically analyzed the relationship between U.S. Food and Drug Administration (FDA) approval and publication of OS evidence to understand better the risks and benefits of delaying approval until OS evidence is available. Using the PACE Continuous Innovation Indicators (CII) platform, we analyzed the effects of cancer type, treatment goal, and year of approval on the lag time between FDA approval and publication of first significant OS finding for 53 treatments approved between 1952 and 2016 for 10 cancer types (n = 71 approved indications). Greater than 59% of treatments were approved before significant OS data for the approved indication were published. Of the drugs in the sample, 31% had lags between approval and first published OS evidence of 4 years or longer. The average number of years between approval and first OS evidence varied by cancer type and did not reliably predict the eventual amount of OS evidence accumulated. Striking the right balance between early access and minimizing risk is a central challenge for regulators worldwide. We illustrate that endpoints other than OS have long helped to provide timely access to new medicines, including many current standards of care. We found that many critical drugs are approved many years before OS data are published, and that OS may not be the most appropriate endpoint in some treatment contexts. Our examination of approved treatments without significant OS data suggests contexts where OS may not be the most relevant endpoint and highlights the importance of using a wide variety of fit-for-purpose evidence types in the approval process.

Post-SELEX optimization of aptamers.

PubMed

Gao, Shunxiang; Zheng, Xin; Jiao, Binghua; Wang, Lianghua

2016-07-01

Aptamers are functional single-stranded DNA or RNA oligonucleotides, selected in vitro by SELEX (Systematic Evolution of Ligands by Exponential Enrichment), which can fold into stable unique three-dimensional structures that bind their target ligands with high affinity and specificity. Although aptamers show a number of favorable advantages such as better stability and easier modification when compared with the properties of antibodies, only a handful of aptamers have entered clinical trials and only one, pegaptanib, has received US Food and Drug Administration approval for clinical use. The main reasons that limit the practical application of aptamers are insufficient nuclease stability, bioavailability, thermal stability, or even affinity. Some aptamers obtained from modified libraries show better properties; however, polymerase amplification of nucleic acids containing non-natural bases is currently a primary drawback of the SELEX process. This review focuses on several post-SELEX optimization strategies of aptamers identified in recent years. We describe four common methods in detail: truncation, chemical modification, bivalent or multivalent aptamer construction, and mutagenesis. We believe that these optimization strategies should improve one or more specific properties of aptamers, and the type of feature(s) selected for improvement will be dependent on the application purpose.

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

38 CFR 21.292 - Course approvals.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Course approvals. 21.292... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only those courses approved by the Department of Veterans Affairs shall be utilized to provide training and...

38 CFR 21.292 - Course approvals.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Course approvals. 21.292... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only those courses approved by the Department of Veterans Affairs shall be utilized to provide training and...

38 CFR 21.292 - Course approvals.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Course approvals. 21.292... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only those courses approved by the Department of Veterans Affairs shall be utilized to provide training and...

38 CFR 21.292 - Course approvals.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Course approvals. 21.292... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only those courses approved by the Department of Veterans Affairs shall be utilized to provide training and...

38 CFR 21.292 - Course approvals.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Course approvals. 21.292... Course Approval and Facility Selection § 21.292 Course approvals. (a) Courses must be approved. Only those courses approved by the Department of Veterans Affairs shall be utilized to provide training and...

Post traumatic stress disorder in children after tsunami disaster in Thailand: 2 years follow-up.

PubMed

Piyasil, Vinadda; Ketuman, Panom; Plubrukarn, Ratnotai; Jotipanut, Vajiraporn; Tanprasert, Somsong; Aowjinda, Sumitra; Thaeeromanophap, Somchit

2007-11-01

On December 26, 2004, the tsunami destroyed many families, communities, and residential areas. Adverse psychological impact on children and adolescents due to a natural disaster of this magnitude has never been reported in Thailand's history particularly as Post-Traumatic Stress Disorder (PTSD). Investigate clinical symptoms and develop a 2-year monitoring and intervention program for PTSD in children affected by the December 26, 2004 tsunami natural disaster The study period started six weeks after the event and was completed after two years. One thousand six hundred and twenty five surviving students from two schools in Takuapa district, Phang-nga Province, were enrolled. Screening tests using Pediatric symptom checklists, Childhood depressive intervention (CDI), and Revised child impact of events scales (CRIES) were done. Psychiatric evaluations were done by child and adolescent psychiatrists. Post Traumatic Stress Disorder (PTSD) was diagnosed using criteria from Diagnostic and Statistical Manual of Mental Disorders, 4th edition. The prevalence of PSTD in the affected students were 57.3, 46.1, 31.6, 10.4, and 7.6% at 6 weeks, 6 months, 1 year, 1 1/2 years, and 2 years, respectively. The female: male ratio was 1.7:1. The peak age was 9-10 years old. Threatened situations were studied. Of the 176 students who risked their lives in the waves, 48 (27.3%) suffered from PTSD. Meanwhile, of the 1314 students who were not hit by the waves but were among affected friends and relatives, 42 students (3.1%) suffered from PTSD. The prevalence of PTSD in those hit by the waves were significantly higher than those who were not [p-value < 0.01, RR = 5.16 (4.04-.6.6)]. The prevalence of PSTD in children who suffered from the tsunami disaster was as high as 57.3% at six weeks after the incident. It declined sharply at two years (7.6%) with the help of integrated welfare. The children continue to get financial, rehabilitation, and mental health support to prevent long

24 CFR 968.320 - HUD review and approval of comprehensive plan (including five-year action plan).

Code of Federal Regulations, 2012 CFR

2012-04-01

... modifications required to make the comprehensive plan approvable. The PHA must re-submit the comprehensive plan... writing containing any false, fictitious or fraudulent statement or entry, in any matter within the...

24 CFR 968.320 - HUD review and approval of comprehensive plan (including five-year action plan).

Code of Federal Regulations, 2011 CFR

2011-04-01

... modifications required to make the comprehensive plan approvable. The PHA must re-submit the comprehensive plan... writing containing any false, fictitious or fraudulent statement or entry, in any matter within the...

78 FR 65030 - Agency Requests for Renewal of a Previously Approved Information Collection(s): Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... Previously Approved Information Collection(s): Approval of Underwriters of Marine Hull Insurance AGENCY...: Approval of Underwriters of Marine Hull Insurance. Form Numbers: None. Type of Review: Renewal of an... approval of marine hull underwriters to insure Maritime Administration program vessels. Foreign and...

Are medical students satisfied with rural community posting? A survey among final year students in medical schools of south-east Nigeria.

PubMed

Ossai, Edmund N; Azuogu, Benedict N; Uwakwe, Kenechi A; Anyanwagu, Uchenna C; Ibiok, Ntat C; Ekeke, Ngozi

2016-01-01

The aim of the study was to determine whether final year medical students in medical schools of south-east Nigeria were satisfied with rural community posting. A cross-sectional descriptive study design was used. All final year medical students in the six medical schools in south-east Nigeria who had completed their rural community posting and were willing to participate were included in the study. The students were interviewed using a pretested, self-administered questionnaire. A total of 457 medical students participated in the study, representing a response rate of 86.7%. Only a minor proportion of the students (22.5%) were satisfied with rural community posting. The most common reason for dissatisfaction among the students was lack of interest in rural communities. Most students (68.7%) were of the opinion that a good rural community posting could influence the students to practise in a rural area after graduation. Factors associated with satisfaction with rural community posting included being a student in a federal institution (adjusted odds ratio (AOR)=0.6, 95% confidence interval (CI)=0.4-0.9), being a male student (AOR=2.4, 95%CI=1.5-3.9) and intention to specialize in community medicine after graduation (AOR=2.7, 95%CI=1.2-6.0). Most students were dissatisfied with rural community postings and the major reason for dissatisfaction was lack of interest in rural communities. A properly organized rural community posting is capable of changing the negative attitude of the students towards life and medical practice in the rural area. Adequate orientation of the students on the relevance of the posting, good community exposure and enhanced student lecturer interactions during the posting period could ensure satisfaction of the students. There should be a targeted evaluation of the rural community posting at the various medical schools in the country with the aim of strengthening and modifying the posting where necessary so as to ensure its purpose is realized.

Change of sleep quality from pre- to 3 years post-solid organ transplantation: The Swiss Transplant Cohort Study

PubMed Central

Denhaerynck, Kris; Huynh-Do, Uyen; Binet, Isabelle; Hadaya, Karine; De Geest, Sabina

2017-01-01

Background Poor sleep quality (SQ) is common after solid organ transplantation; however, very little is known about its natural history. We assessed the changes in SQ from pre- to 3 years post-transplant in adult heart, kidney, liver and lung recipients included in the prospective nation-wide Swiss Transplant Cohort Study. We explored associations with selected variables in patients suffering persistent poor SQ compared to those with good or variable SQ. Methods Adult single organ transplant recipients enrolled in the Swiss Transplant Cohort Study with pre-transplant and at least 3 post-transplant SQ assessment data were included. SQ was self-reported pre-transplant (at listing), then at 6, 12, 24 and 36 months post-transplant. A single SQ item was used to identify poor (0–5) and good sleepers (6–10). Between organ groups, SQ was compared via logistic regression analysis with generalized estimating equations. Within the group reporting persistently poor SQ, we used logistic regression or Kaplan-Meier analysis as appropriate to check for differences in global quality of life and survival. Results In a sample of 1173 transplant patients (age: 52.1±13.2 years; 65% males; 66% kidney, 17% liver, 10% lung, 7% heart) transplanted between 2008 and 2012, pre- transplant poor SQ was highest in liver (50%) and heart (49%) recipients. Overall, poor SQ decreased significantly from pre-transplant (38%) to 24 months post-transplant (26%) and remained stable at 3 years (29%). Patients reporting persistently poor SQ had significantly more depressive symptomatology and lower global quality of life. Conclusion Because self-reported poor SQ is related to poorer global quality of life, these results emphasize the need for further studies to find suitable treatment options for poor SQ in transplant recipients. PMID:29020112

Long-term treatment effects of the FR-2 appliance: a prospective evalution 7 years post-treatment

PubMed Central

Franchi, Lorenzo; Cevidanes, Lucia H. S.; Scanavini, Marco A.; McNamara, James A.

2014-01-01

AIM To examine the long-term effects induced by treatment with the function regulator (FR-2) appliance 7 years post-treatment compared with untreated class II subjects. SUBJECTS AND METHODS The FR-2 sample was collected prospectively and comprised 17 subjects (10 boys and 7 girls, mean age 10.8 years) who were treated with the FR-2 appliance for 1.7 years and re-evaluated 7.1 years after treatment. The step-by-step mandibular advancement was performed gradually (increments up to 3–4 mm), until a ‘super class I’ molar relationship was obtained. The control group consisted of 17 class II subjects (9 boys and 8 girls, mean age 11.3 years) with class II malocclusion, excessive overjet, and class II molar relationship, matched to the treated group as to ages at all times, gender distribution, and stages of skeletal maturity (evaluated by the cervical vertebral maturation method). The lateral cephalograms were analysed at T1 (initial), T2 (final), and T3 (7.1 years post-treatment). The compatibility between the groups and the comparisons of their changes at T1–T2, T2–T3, and T1–T3 intervals were examined by independent sample t-tests (P < 0.05). RESULTS FR-2 treatment provided a significant improvement in the maxillomandibular relationship due to an increase in mandibular length compared with controls, which remained stable over time. Also overjet, overbite, and molar relationship corrections demonstrated stability. Among dentoalveolar changes, only the increased mesial movement of the mandibular molars in the FR-2 group demonstrated stability. CONCLUSIONS Correction of class II malocclusion remained stable 7 years after FR-2 treatment mainly due to the stability of the skeletal changes. PMID:23736378

Drugs Approved for Brain Tumors

MedlinePlus

... Ask about Your Treatment Research Drugs Approved for Brain Tumors This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Brain Tumors Afinitor (Everolimus) Afinitor Disperz (Everolimus) Avastin (Bevacizumab) ...

38 CFR 21.7720 - Course approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Course approval. 21.7720... of Courses § 21.7720 Course approval. (a) Courses must be approved. (1) A course of education offered...)(iii), and (c)(2)(iv) apply. (3) A course approved under 38 U.S.C. chapter 36 is approved for purposes...

38 CFR 21.7720 - Course approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Course approval. 21.7720... of Courses § 21.7720 Course approval. (a) Courses must be approved. (1) A course of education offered...)(iii), and (c)(2)(iv) apply. (3) A course approved under 38 U.S.C. chapter 36 is approved for purposes...

38 CFR 21.7720 - Course approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Course approval. 21.7720... of Courses § 21.7720 Course approval. (a) Courses must be approved. (1) A course of education offered...)(iii), and (c)(2)(iv) apply. (3) A course approved under 38 U.S.C. chapter 36 is approved for purposes...

38 CFR 21.7720 - Course approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Course approval. 21.7720... of Courses § 21.7720 Course approval. (a) Courses must be approved. (1) A course of education offered...)(iii), and (c)(2)(iv) apply. (3) A course approved under 38 U.S.C. chapter 36 is approved for purposes...

Meta-analysis: pre-operative infliximab treatment and short-term post-operative complications in patients with ulcerative colitis.

PubMed

Yang, Z; Wu, Q; Wu, K; Fan, D

2010-02-15

Infliximab was approved for use in ulcerative colitis in recent years. It has been debated if infliximab increases the risk of post-operative complications in patients with ulcerative colitis. To perform a meta-analysis that examines the relationship between preoperative infliximab treatment and short-term post-operative complications in patients with ulcerative colitis. We searched the PubMed and MEDLINE databases to identify observational studies on the impact of pre-operative infliximab use on short-term post-operative complications in ulcerative colitis. Infectious complications mainly included wound infection, sepsis and abscess, whereas non-infectious complications included intestinal obstruction, thromboembolism and gastrointestinal haemorrhage. Pooled odds ratios (ORs) were calculated for each relationship. A total of 5 studies and 706 patients were included in our meta-analysis. Overall, we did not find a strong association between pre-operative treatment of infliximab and short-term infectious [OR 2.24, 95% confidence interval (CI) 0.63-7.95] or non-infectious (OR 0.85, 95% CI 0.50-1.45) post-operative complications in ulcerative colitis patients. On the contrary, we discovered that pre-operative infliximab use increased short-term total post-operative complications (OR 1.80, 95% CI 1.12-2.87). Pre-operative infliximab use increased the risk of short-term post-operative complications. Subgroup analysis is underpowered to assess the nature of these complications but shows a trend towards increased post-operative infection.

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

PubMed

Downing, Nicholas S; Shah, Nilay D; Aminawung, Jenerius A; Pease, Alison M; Zeitoun, Jean-David; Krumholz, Harlan M; Ross, Joseph S

2017-05-09

Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near-regulatory deadline approval, and regulatory review time. A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001

Factors associated with remission of post-traumatic brain injury fatigue in the years following traumatic brain injury (TBI): a TBI model systems module study.

PubMed

Lequerica, Anthony H; Botticello, Amanda L; Lengenfelder, Jean; Chiaravalloti, Nancy; Bushnik, Tamara; Dijkers, Marcel P; Hammond, Flora M; Kolakowsky-Hayner, Stephanie A; Rosenthal, Joseph

2017-10-01

Post-traumatic brain injury fatigue (PTBIF) is a major problem in the years after traumatic brain injury (TBI), yet little is known about its persistence and resolution. The objective of the study was to identify factors related to PTBIF remission and resolution. TBI Model System registrants at five centres participated in interviews at either one and two years post-injury (Y1-2 Cohort), or two and five years post-injury (Y2-5 Cohort). Characteristics of participants with PTBIF remission were compared to those with PTBIF persistence. Variables studied included the presence of and changes in disability, sleep dysfunction, mood, and community participation. The Functional Independence Measure did not differ significantly between groups or over time. In the Y1-2 Cohort the Fatigue Resolved group scored significantly better on the Disability Rating Scale and Pittsburgh Sleep Quality Index. In the Y2-5 Cohort the Fatigue Resolved group scored significantly higher on a measure of community participation. It was concluded that fewer than half of the sample in each cohort experienced a remission of PTBIF between time points. Persistence of PTBIF 1-2 years post-injury is associated with disability, sleep disturbance, and depression while persistence of fatigue beyond 2 years post-injury appears to be related to participation level, underscoring the potential impact of effective surveillance, assessment, and treatment of this condition in optimising life after TBI. Differences in fatigue progression may point to the presence of different types of PTBIF.

Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

PubMed

Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

2015-06-01

All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

PubMed

Lawrence, Dana J

2011-11-01

To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby

Post-remission treatment with allogeneic stem cell transplantation in patients aged 60 years and older with acute myeloid leukaemia: a time-dependent analysis.

PubMed

Versluis, Jurjen; Hazenberg, Carin L E; Passweg, Jakob R; van Putten, Wim L J; Maertens, Johan; Biemond, Bart J; Theobald, Matthias; Graux, Carlos; Kuball, Jurgen; Schouten, Harry C; Pabst, Thomas; Löwenberg, Bob; Ossenkoppele, Gert; Vellenga, Edo; Cornelissen, Jan J

2015-10-01

Acute myeloid leukaemia mainly affects elderly people, with a median age at diagnosis of around 70 years. Although about 50-60% of patients enter first complete remission upon intensive induction chemotherapy, relapse remains high and overall outcomes are disappointing. Therefore, effective post-remission therapy is urgently needed. Although often no post-remission therapy is given to elderly patients, it might include chemotherapy or allogeneic haemopoietic stem cell transplantation (HSCT) following reduced-intensity conditioning. We aimed to assess the comparative value of allogeneic HSCT with other approaches, including no post-remission therapy, in patients with acute myeloid leukaemia aged 60 years and older. For this time-dependent analysis, we used the results from four successive prospective HOVON-SAKK acute myeloid leukaemia trials. Between May 3, 2001, and Feb 5, 2010, a total of 1155 patients aged 60 years and older were entered into these trials, of whom 640 obtained a first complete remission after induction chemotherapy and were included in the analysis. Post-remission therapy consisted of allogeneic HSCT following reduced-intensity conditioning (n=97), gemtuzumab ozogamicin (n=110), chemotherapy (n=44), autologous HSCT (n=23), or no further treatment (n=366). Reduced-intensity conditioning regimens consisted of fludarabine combined with 2 Gy of total body irradiation (n=71), fludarabine with busulfan (n=10), or other regimens (n=16). A time-dependent analysis was done, in which allogeneic HSCT was compared with other types of post-remission therapy. The primary endpoint of the study was 5-year overall survival for all treatment groups, analysed by a time-dependent analysis. 5-year overall survival was 35% (95% CI 25-44) for patients who received an allogeneic HSCT, 21% (17-26) for those who received no additional post-remission therapy, and 26% (19-33) for patients who received either additional chemotherapy or autologous HSCT. Overall survival at 5

Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration

PubMed Central

Herz, Naomi; Loyo-Berrios, Nilsa; Tarver, Michelle

2014-01-01

Abstract Background: Disease presentation, prevalence, and treatment effects vary by sex, thus it is important to ensure adequate participation of both sexes in medical device post-approval studies (PAS). Methods: The goals of this study were to determine the participation rate of women in PAS mandated by the Food and Drug Administration (FDA) and if participation varied by clinical area. The study also evaluated the frequency in which enrollment by sex is reported by applicant reports and FDA reviews, as well as the frequency in which final study reports analyze whether outcomes differ by sex. Results: Of 89 studies with enrollment completed, data on sex of participants were available in 93% of submitted reports, while data on enrollment by sex was evaluated and noted in 43% of FDA review memos. Study participation varied by clinical area, with female participation ranging from 32% in cardiovascular PAS to 90% in PAS for reconstructive devices. Of 53 completed studies, data on enrollment by sex was provided in 49 of the final reports. Of these 14% included a multivariate analysis that included sex as a covariate and 4% included a subgroup analysis for female participants. Conclusions: Data on sex was not routinely assessed in FDA reviews. Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews. FDA will continue working with applicants to develop PAS that enroll and retain proportions of women consistent with the sex-specific prevalence for the disease or condition the device is used to treat. PMID:24405314

Twenty-Five Years of Gene Therapy for ADA-SCID: From Bubble Babies to an Approved Drug.

PubMed

Ferrua, Francesca; Aiuti, Alessandro

2017-11-01

Twenty-five years have passed since first attempts of gene therapy (GT) in children affected by severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) defect, also known by the general public as bubble babies. ADA-SCID is fatal early in life if untreated. Unconditioned hematopoietic stem cell (HSC) transplant from matched sibling donor represents a curative treatment but is available for few patients. Enzyme replacement therapy can be life-saving, but its chronic use has many drawbacks. This review summarizes the history of ADA-SCID GT over the last 25 years, starting from first pioneering studies in the early 1990s using gamma-retroviral vectors, based on multiple infusions of genetically corrected autologous peripheral blood lymphocytes. HSC represented the ideal target for gene correction to guarantee production of engineered multi-lineage progeny, but it required a decade to achieve therapeutic benefit with this approach. Introduction of low-intensity conditioning represented a crucial step in achieving stable gene-corrected HSC engraftment and therapeutic levels of ADA-expressing cells. Recent clinical trials demonstrated that gamma-retroviral GT for ADA-SCID has a favorable safety profile and is effective in restoring normal purine metabolism and immune functions in patients >13 years after treatment. No abnormal clonal proliferation or leukemia development have been observed in >40 patients treated experimentally in five different centers worldwide. In 2016, the medicinal product Strimvelis™ received marketing approval in Europe for patients affected by ADA-SCID without a suitable human leukocyte antigen-matched related donor. Positive safety and efficacy results have been obtained in GT clinical trials using lentiviral vectors encoding ADA. The results obtained in last 25 years in ADA-SCID GT development fundamentally contributed to improve patients' prognosis, together with earlier diagnosis thanks to newborn screening. These advances

Results of thoracic endovascular aortic repair 6 years after United States Food and Drug Administration approval.

PubMed

Shah, Asad A; Barfield, Michael E; Andersen, Nicholas D; Williams, Judson B; Shah, Julie A; Hanna, Jennifer M; McCann, Richard L; Hughes, G Chad

2012-11-01

Since United States Food and Drug Administration approval in 2005, the short-term safety and efficacy of thoracic endovascular aortic repair (TEVAR) have been established. However, longer-term follow-up data remain lacking. The objective of this study is to report 6-year outcomes of TEVAR in clinical practice. A prospective cohort review was performed of all patients undergoing TEVAR at a single referral institution between March 2005 and May 2011. Rates of reintervention were noted. Overall and aortic-specific survival were determined using Kaplan-Meier methods. Log-rank tests were used to compare survival between groups. During the study interval, 332 TEVAR procedures were performed in 297 patients. Reintervention was required after 12% of procedures at a mean of 8 ± 14 months after initial TEVAR and was higher in the initial tercile of patients (15.0% vs 9.9%). The 6-year freedom from reintervention was 84%. Type I endoleak was the most common cause of reintervention (5%). Six-year overall survival was 54%, and aorta-specific survival was 92%. Long-term survival was significantly lower than that of an age- and sex-matched United States population (p < 0.001). Survival was similar between patients requiring a reintervention vs those not (p = 0.26). Survival was different based on indication for TEVAR (p = 0.007), and patients with degenerative aneurysms had the lowest survival (47% at 6 years). Cardiopulmonary pathologies were the most common cause of death (27 of 93 total deaths). Long-term aortic-related survival after TEVAR is high, and the need for reintervention is infrequent. However, overall long-term survival is low, particularly for patients with degenerative aneurysms, and additional work is needed to identify patients unlikely to derive a survival benefit from TEVAR. Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

77 FR 59616 - Medicare and Medicaid Programs; Approval of the American Osteopathic Association/Healthcare...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3264-FN... Accreditation Program (AOA/HFAP) Application for Continuing CMS-Approval of Its Ambulatory Surgical Center (ASC... 6 years or sooner as determined by CMS. AOA/HFAP's current term of approval for their ASC...

77 FR 70446 - Medicare and Medicaid Programs; Approval of the American Association for Accreditation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

... Surgery Facilities (AAAASF) for Continuing CMS Approval of Its Ambulatory Surgical Center Accreditation... announces our decision to approve the American Association for Accreditation of Ambulatory Surgery... years or sooner as determined by CMS. American Association for Accreditation of Ambulatory Surgery...

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to... to any Approval Authority. (b) Each application must include the following for each container: (1...

30 CFR 7.49 - Approval marking.

Code of Federal Regulations, 2010 CFR

2010-07-01

... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box. ...

30 CFR 7.49 - Approval marking.

Code of Federal Regulations, 2012 CFR

2012-07-01

... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box. ...

30 CFR 7.49 - Approval marking.

Code of Federal Regulations, 2011 CFR

2011-07-01

... MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Battery Assemblies § 7.49 Approval marking. Each approved battery assembly shall be identified by a legible and permanent approval plate inscribed with the assigned MSHA approval number and securely attached to the battery box. ...

77 FR 3611 - Approval and Promulgation of Implementation Plans; North Carolina: Approval of Section 110(a)(1...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

... 27.73 4.94 35.88 56.14 Guilford 1.06 2.01 42.78 11.83 57.68 115.36 Total 6.07 3.83 90.62 21.11 121.63... of the 1997 8-hour ozone NAAQS through the year 2018 in the Triad Area. EPA is approving these SIP... 2018 for this attainment area. The May 18, 2011, supplemental information contained Appendix C SESARM...

25 CFR 533.3 - Submission of management contract for approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) For new contracts and new operations, a three (3)-year business plan which sets forth the parties... operations, a three (3)-year business plan which sets forth the parties' goals, objectives, budgets... 25 Indians 2 2010-04-01 2010-04-01 false Submission of management contract for approval. 533.3...

Media triggers of post-traumatic stress disorder 50 years after the Second World War.

PubMed

Hilton, C

1997-08-01

Post-traumatic stress disorder (PTSD) may present many years after the original trauma. Case studies of two elderly patients are described. Both had experienced life-threatening combat situations and witnessed intense suffering during the Second World War. Marked distress was triggered by the media commemorating the fiftieth anniversary of the end of the war. PTSD patients often avoid talking of their traumatic experiences because of associated distress. Without taking a military and trauma history from elderly patients the diagnosis is likely to be missed.

Post-Closure Inspection Report for the Tonopah Test Range, Nevada, for Calendar Year 2012

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

NSTec Environmental Restoration

2013-01-28

This report provides the results of the annual post-closure inspections conducted at the closed Corrective Action Units (CAUs) located on the Tonopah Test Range (TTR), Nevada. This report covers calendar year 2012 and includes inspection and repair activities completed at the following CAUs: · CAU 400: Bomblet Pit and Five Points Landfill (TTR) · CAU 407: Roller Coaster RadSafe Area (TTR) · CAU 424: Area 3 Landfill Complexes (TTR) · CAU 453: Area 9 UXO Landfill (TTR) · CAU 487: Thunderwell Site (TTR)

Normative feedback for parents of college students: piloting a parent based intervention to correct misperceptions of students' alcohol use and other parents' approval of drinking.

PubMed

Labrie, Joseph W; Napper, Lucy E; Hummer, Justin F

2014-01-01

Multi-component parent-based interventions (PBIs) provide a promising avenue for targeting alcohol use and related consequences in college students. Parents of college-aged children can have a significant influence on their children's alcohol use decisions. However, parents tend to underestimate their own child's alcohol use and overestimate other similar parents' approval of student drinking. These misperceptions could have important implications for parents' own attitudes and alcohol-related communication with their student. Targeting these misperceptions through normative feedback could help promote greater and more in-depth alcohol-related communication. The present study examines the potential efficacy of web-based alcohol-related normative feedback for parents of college students. A sample of 144 parents of college students received web-based normative feedback about students' alcohol use and approval, as well as other same-college parents' alcohol approval. Parents completed measures of perceived student alcohol use, student alcohol approval, other-parent alcohol approval, and intentions to discuss alcohol use both pre- and post-normative feedback. Post-feedback, parents reported stronger intentions to talk to their student about alcohol, were less confident in their knowledge of their students' alcohol use, and believed that their student drank in greater quantity and more frequently than pre-feedback. Parents also perceived other parents to be less approving of alcohol use after viewing normative feedback. These findings provide preliminary support for the use of web-based normative feedback for parents of college students. Given these promising results, further research developing and testing this approach merits attention. © 2013.

Normative Feedback for Parents of College Students: Piloting a Parent Based Intervention to Correct Misperceptions of Students’ Alcohol Use and Other Parents’ Approval of Drinking

PubMed Central

LaBrie, Joseph W.; Napper, Lucy E.; Hummer, Justin F.

2013-01-01

Objective Multi-component parent-based interventions (PBIs) provide a promising avenue for targeting alcohol use and related consequences in college students. Parents of college-aged children can have a significant influence on their children’s alcohol use decisions. However, parents tend to underestimate their own child’s alcohol use and overestimate other similar parents’ approval of student drinking. These misperceptions could have important implications for parents’ own attitudes and alcohol-related communication with their student. Targeting these misperceptions through normative feedback could help promote greater and more in-depth alcohol-related communication. The present study examines the potential efficacy of web-based alcohol-related normative feedback for parents of college students. Method A sample of 144 parents of college students received web-based normative feedback about students’ alcohol use and approval, as well as other same-college parents’ alcohol approval. Parents completed measures of perceived student alcohol use, student alcohol approval, other-parent alcohol approval, and intentions to discuss alcohol use both pre- and post-normative feedback. Results Post-feedback, parents reported stronger intentions to talk to their student about alcohol, were less confident in their knowledge of their students’ alcohol use, and believed that their student drank in greater quantity and more frequently than pre-feedback. Parents also perceived other parents to be less approving of alcohol use after viewing normative feedback. Conclusions These findings provide preliminary support for the use of web-based normative feedback for parents of college students. Given these promising results, further research developing and testing this approach merits attention. PMID:24099892

Steady Stream of High School Graduates Enter B.C. Public Post-Secondary Education for the First Time Each Year. Research Results from the Student Transitions Project

ERIC Educational Resources Information Center

Student Transitions Project, 2014

2014-01-01

The Student Transition project (STP) has collected eleven years of grade 12 and post-secondary enrollment data, since it's inception in 2003. This information is used to track student transitions from grade 12 graduation into post-secondary education, student mobility between post-secondary institutions and post-secondary credential completions.…

40 CFR 52.76 - 1990 Base Year Emission Inventory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 3 2011-07-01 2011-07-01 false 1990 Base Year Emission Inventory. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Alaska § 52.76 1990 Base Year Emission Inventory. (a) EPA approves as a revision to the Alaska State Implementation Plan the 1990 Base Year Carbon...

40 CFR 52.423 - 1990 Base Year Emission Inventory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 3 2011-07-01 2011-07-01 false 1990 Base Year Emission Inventory. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Delaware § 52.423 1990 Base Year Emission Inventory. EPA approves as a revision to the Delaware State Implementation Plan the 1990 base year emission...

40 CFR 52.423 - 1990 Base Year Emission Inventory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 3 2013-07-01 2013-07-01 false 1990 Base Year Emission Inventory. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Delaware § 52.423 1990 Base Year Emission Inventory. EPA approves as a revision to the Delaware State Implementation Plan the 1990 base year emission...

40 CFR 52.423 - 1990 Base Year Emission Inventory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 3 2012-07-01 2012-07-01 false 1990 Base Year Emission Inventory. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Delaware § 52.423 1990 Base Year Emission Inventory. EPA approves as a revision to the Delaware State Implementation Plan the 1990 base year emission...

40 CFR 52.76 - 1990 Base Year Emission Inventory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 3 2012-07-01 2012-07-01 false 1990 Base Year Emission Inventory. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Alaska § 52.76 1990 Base Year Emission Inventory. (a) EPA approves as a revision to the Alaska State Implementation Plan the 1990 Base Year Carbon...

40 CFR 52.76 - 1990 Base Year Emission Inventory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 3 2013-07-01 2013-07-01 false 1990 Base Year Emission Inventory. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Alaska § 52.76 1990 Base Year Emission Inventory. (a) EPA approves as a revision to the Alaska State Implementation Plan the 1990 Base Year Carbon...

40 CFR 52.2425 - 1990 Base Year Emission Inventory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 4 2011-07-01 2011-07-01 false 1990 Base Year Emission Inventory. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virginia § 52.2425 1990 Base Year Emission Inventory. (a) EPA approves as a revision to the Virginia Implementation Plan the 1990 base year...

40 CFR 52.76 - 1990 Base Year Emission Inventory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 3 2010-07-01 2010-07-01 false 1990 Base Year Emission Inventory. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Alaska § 52.76 1990 Base Year Emission Inventory. (a) EPA approves as a revision to the Alaska State Implementation Plan the 1990 Base Year Carbon...

40 CFR 52.2425 - 1990 Base Year Emission Inventory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 4 2010-07-01 2010-07-01 false 1990 Base Year Emission Inventory. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Virginia § 52.2425 1990 Base Year Emission Inventory. (a) EPA approves as a revision to the Virginia Implementation Plan the 1990 base year...

40 CFR 52.423 - 1990 Base Year Emission Inventory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 3 2010-07-01 2010-07-01 false 1990 Base Year Emission Inventory. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Delaware § 52.423 1990 Base Year Emission Inventory. EPA approves as a revision to the Delaware State Implementation Plan the 1990 base year emission...

77 FR 37000 - Proposed Extension of Approval of Information Collection; Comment Request-Baby Bouncers and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection... of 3 years from the date of approval by the Office of Management and Budget (OMB), of information... walker- jumpers. The collection of information consists of requirements that manufacturers and importers...

Japanese Physicians' Views on Drug Post-Marketing Surveillance.

PubMed

Maeda, Kazuki; Katashima, Rumi; Ishizawa, Keisuke; Yanagawa, Hiroaki

2015-12-01

Registration trials leading to the approval of drugs are paramount in drug development. After approval, continuous efforts are necessary to ensure proper use of the approved drugs. In Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated into GPSP, attention has recently been focused on disassociating them. In this study, we examined physicians' views on PMS with the aim of conducting PMS more effectively. We retrospectively reviewed records between 2009 and 2013 from the institutional review board of Tokushima University Hospital, an academic hospital in rural Japan. The annual number of times PMS was performed was then determined. Next, we assessed physicians' attitudes toward drug PMS, including ethical issues, in a cross-sectional study using a questionnaire designed for this study. Five- and two-point scales were used. The questionnaire was distributed in 2014 to 221 physicians listed as investigators in PMS contracts. Of the 221 physicians, 103 (46.6%) responded to the questionnaire. About 50% of the respondents had experience writing PMS reports. Many of the physicians considered PMS to be important but burdensome. Furthermore, from the viewpoint of research ethics, many physicians considered it improper within the present PMS framework to collect and provide data beyond the scope of routine clinical practice without obtaining informed consent in the case of extra blood sampling, provision of images, monitoring and controlled studies. Beyond practical factors such as workload, attention should be given to establishing an ethical infrastructure and globally harmonized system with regard to the Japanese PMS system. Given the limitations of this single-institution study, further research is needed to collect information for developing a suitable infrastructure.

Mortality, nutrition and health in Lofa County Liberia five years post-conflict.

PubMed

Doocy, Shannon; Lewy, Daniela; Guenther, Tanya; Larrance, Ryan

2010-01-01

Liberia remains in transition from a state of humanitarian emergency to development, and Lofa County was the epicentre of recent conflict. This study aimed to estimate mortality and malnutrition and evaluate access to health services, water and sanitation. The survey was conducted in April 2009 and employed a 46 cluster×20 design (n=920 households) with probability proportional to size sampling. The crude mortality rate was 24.3/1000/year (CI: 19.0 to 29.6) or 0.67/10,000/day (CI: 0.52 to 0.81). The global acute malnutrition rate was 7.9% (CI: 5.4 to 8.9), and the severe acute malnutrition rate was 4.5% (CI: 2.9 to 6.7). Access to basic health services was relatively good according to a variety of indicators; however, access to sanitation was low, with 39.5% of households reporting access to toilets or latrines. Despite high rates of displacement and infrastructure destruction, population health appears to be relatively stable 5 years post-conflict, though a continued focus on reconstruction and development is needed.

77 FR 42497 - Information Collection(s) Being Submitted for Review and Approval to the Office of Management and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-19

... officer (a post staffed 24 hours a day) in the FCC's Communications and Crisis Management Center in... Approval to the Office of Management and Budget (OMB) AGENCY: Federal Communications Commission. ACTION... comments to Nicholas A. Fraser, Office of Management and Budget (OMB), via fax at 202-395-5167 or via...

42 CFR 62.9 - Under what circumstances can the period of obligated service be deferred to complete approved...

Code of Federal Regulations, 2013 CFR

2013-10-01

... obligated service be deferred to complete approved graduate training? 62.9 Section 62.9 Public Health PUBLIC... approved graduate training? (a) Requested deferment. Upon the request of any participant receiving a degree... complete an approved graduate training program. The period of this deferment may not exceed (1) three years...

42 CFR 62.9 - Under what circumstances can the period of obligated service be deferred to complete approved...

Code of Federal Regulations, 2012 CFR

2012-10-01

... obligated service be deferred to complete approved graduate training? 62.9 Section 62.9 Public Health PUBLIC... approved graduate training? (a) Requested deferment. Upon the request of any participant receiving a degree... complete an approved graduate training program. The period of this deferment may not exceed (1) three years...

42 CFR 62.9 - Under what circumstances can the period of obligated service be deferred to complete approved...

Code of Federal Regulations, 2014 CFR

2014-10-01

... obligated service be deferred to complete approved graduate training? 62.9 Section 62.9 Public Health PUBLIC... approved graduate training? (a) Requested deferment. Upon the request of any participant receiving a degree... complete an approved graduate training program. The period of this deferment may not exceed (1) three years...

42 CFR 84.50 - Types of respirators to be approved; scope of approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

42 CFR 84.50 - Types of respirators to be approved; scope of approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

42 CFR 84.50 - Types of respirators to be approved; scope of approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

42 CFR 84.50 - Types of respirators to be approved; scope of approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

42 CFR 84.50 - Types of respirators to be approved; scope of approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... provide respiratory protection for fixed periods of time against the hazards specified in such approval. ...

28 CFR 2.41 - Travel approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Travel approval. 2.41 Section 2.41..., YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.41 Travel approval. (a) The probation officer may approve travel outside the district without approval of the...

40 CFR 52.1522 - Approval status.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves New Hampshire's plan as... Federal approval of State issued new source review permits pursuant to section 173 of the Clean Air Act...

40 CFR 52.1522 - Approval status.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves New Hampshire's plan as... Federal approval of State issued new source review permits pursuant to section 173 of the Clean Air Act...

40 CFR 52.1522 - Approval status.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves New Hampshire's plan as... Federal approval of State issued new source review permits pursuant to section 173 of the Clean Air Act...

40 CFR 52.1522 - Approval status.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Hampshire § 52.1522 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves New Hampshire's plan as... Federal approval of State issued new source review permits pursuant to section 173 of the Clean Air Act...

40 CFR 52.1075 - Base year emissions inventory.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 4 2013-07-01 2013-07-01 false Base year emissions inventory. 52.1075... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1075 Base year emissions inventory. (a) EPA approves as a revision to the Maryland State Implementation Plan the 1990 base...

40 CFR 52.1075 - Base year emissions inventory.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 4 2012-07-01 2012-07-01 false Base year emissions inventory. 52.1075... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1075 Base year emissions inventory. (a) EPA approves as a revision to the Maryland State Implementation Plan the 1990 base...

40 CFR 52.1075 - Base year emissions inventory.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 4 2011-07-01 2011-07-01 false Base year emissions inventory. 52.1075... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Maryland § 52.1075 Base year emissions inventory. (a) EPA approves as a revision to the Maryland State Implementation Plan the 1990 base...

Self-Perceived Participation and Autonomy at 1-Year Post Stroke: A Part of the Stroke Arm Longitudinal Study at the University of Gothenburg (SALGOT Study).

PubMed

Törnbom, Karin; Hadartz, Kristin; Sunnerhagen, Katharina S

2018-04-01

Identifying factors predicting the long-term outcome of participation and autonomy after stroke is essential for developing individualized rehabilitation interventions. The aim was to describe self-assessed participation and autonomy and to explore factors associated with the same at 1 year post stroke. Participants consisted of 79 persons (mean age = 67) with a first-time stroke at the 1-year follow-up. To investigate perceived participation and autonomy at 1 year, a self-assessment questionnaire, the Impact on Participation and Autonomy-English version (IPA-E) was used. Multivariate logistic regression models were performed using age, gender, stroke severity, and functional dependency at discharge as potential contributors to the perceived level of participation and autonomy. A high percentage (70%-88%) evaluated their functions as fair to very good within all domains of the IPA-E at 1 year post stroke. However, around a fifth experienced their Family role as poor to very poor. Participants' functional dependency at discharge significantly influenced the outcome for the domains of Family role (odds ratio [OR] = 5.66, P < .01), Social relations (OR = 3.23, P < .03), and Autonomy indoors (OR = 3.44, P < .04) at 1 year post stroke. Aspects of the Family role domain deserve further attention in interventions aimed at improving participation and autonomy at 1 year post stroke. The results also indicate that supporting indoor autonomy and social relations of persons with stroke during the acute rehabilitation is important to enhance participation and autonomy at 1 year post stroke. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

46 CFR 11.302 - Course approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 1 2013-10-01 2013-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

46 CFR 11.302 - Course approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 1 2011-10-01 2011-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

46 CFR 11.302 - Course approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 1 2010-10-01 2010-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

46 CFR 11.302 - Course approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 1 2012-10-01 2012-10-01 false Course approval. 11.302 Section 11.302 Shipping COAST... ENDORSEMENTS Training Schools with Approved Courses § 11.302 Course approval. (a) The Coast Guard approves courses satisfying regulatory requirements and those that substitute for a Coast Guard examination or a...

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

PubMed Central

Downing, Nicholas S.; Shah, Nilay D.; Aminawung, Jenerius A.; Pease, Alison M.; Zeitoun, Jean-David; Krumholz, Harlan M.

2017-01-01

Importance Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. Objectives To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Design and Setting Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Exposures Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near–regulatory deadline approval, and regulatory review time. Main Outcomes and Measures A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. Results From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for

38 CFR 21.7220 - Course approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Course approval. 21.7220... Bill-Active Duty) Approval of Courses § 21.7220 Course approval. (a) Courses must be approved. (1) A course of education, including the class schedules of a resident course not leading to a standard college...

38 CFR 21.7220 - Course approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Course approval. 21.7220... Bill-Active Duty) Approval of Courses § 21.7220 Course approval. (a) Courses must be approved. (1) A course of education, including the class schedules of a resident course not leading to a standard college...

38 CFR 21.7220 - Course approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Course approval. 21.7220... Bill-Active Duty) Approval of Courses § 21.7220 Course approval. (a) Courses must be approved. (1) A course of education, including the class schedules of a resident course not leading to a standard college...

38 CFR 21.7220 - Course approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Course approval. 21.7220... Bill-Active Duty) Approval of Courses § 21.7220 Course approval. (a) Courses must be approved. (1) A course of education, including the class schedules of a resident course not leading to a standard college...

9 CFR 147.52 - Approved tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In addition...

9 CFR 147.52 - Approved tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In addition...

Atezolizumab: First Global Approval.

PubMed

Markham, Anthony

2016-08-01

Atezolizumab (Tecentriq™)-a monoclonal antibody targeting programmed death ligand 1 (PD-L1 or CD274 antigen)-is being developed by Genentech as treatment for a variety of haematological malignancies and solid tumours. It been approved in the US as a second-line therapy for urothelial carcinoma and is awaiting approval as a second-line therapy for non-small cell lung cancer. This article summarizes the milestones in the development of atezolizumab leading to this first approval for urothelial carcinoma.

78 FR 65419 - Approval of Noise Compatibility Program for Tucson International Airport, Tucson, Arizona

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... demonstrated noise benefit to noncompatible land uses exposed to noise levels in the yearly day/night average... provision of the Act to approve or disapprove the program within 180 days (other than the use of new or...-day period shall be deemed to be an approval of such program. The Noise Compatibility Program...

75 FR 75373 - Conduct of Employees and Former Employees; Exemption From Post-Employment Restrictions for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-03

...; Exemption From Post- Employment Restrictions for Communications Furnishing Scientific or Technological... of the executive branch may obtain approval from DOE to make communications to DOE solely for the... communications to DOE solely for the purpose of furnishing scientific or technological information during the...

14 CFR 21.325 - Export airworthiness approvals.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Export airworthiness approvals. 21.325... AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Export Airworthiness Approvals § 21.325 Export airworthiness approvals. (a) Kinds of approvals. (1) Export airworthiness approval of Class I products is issued...

Prolonged use of the etonogestrel implant and levonorgestrel intrauterine device: 2 years beyond Food and Drug Administration-approved duration.

PubMed

McNicholas, Colleen; Swor, Erin; Wan, Leping; Peipert, Jeffrey F

2017-06-01

The subdermal contraceptive implant and the 52-mg levonorgestrel intrauterine device are currently Food and Drug Administration approved for 3 and 5 years of use, respectively. Limited available data suggested both of these methods are effective beyond that time. Demonstration of prolonged effectiveness will improve the cost-effectiveness of the device, and potentially patient continuation and satisfaction. We sought to evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device in women using the method for 2 years beyond the current Food and Drug Administration-approved duration. We initiated this ongoing prospective cohort study in January 2012. We are enrolling women using the contraceptive implant or 52-mg levonorgestrel intrauterine device for a minimum of 3 and 5 years, respectively (started intrauterine device in ≥2007 or implant in ≥2009). Demographic and reproductive health histories, as well as objective body mass index, were collected. Implant users were offered periodic venipuncture for analysis of serum etonogestrel levels. The primary outcome, unintended pregnancy rate, was calculated per 100 woman-years. We analyzed baseline demographic characteristics using χ 2 test and Fisher exact test, and compared serum etonogestrel levels stratified by body mass index using the Kruskal-Wallis test. Implant users (n = 291) have contributed 444.0 woman-years of follow-up. There have been no documented pregnancies in implant users during the 2 years of postexpiration follow-up. Calculated failure rates in the fourth and fifth years for the implant are calculated as 0 (1-sided 97.5% confidence interval, 0-1.48) per 100 woman-years at 4 years and 0 (1-sided 97.5% confidence interval, 0-2.65) per 100 woman-years at 5 years. Among 496 levonorgestrel intrauterine device users, 696.9 woman-years of follow-up have been completed. Two pregnancies have been reported. The failure rate in the sixth year of use of the

Differentiating maternal fatigue and depressive symptoms at six months and four years post partum: Considerations for assessment, diagnosis and intervention.

PubMed

Giallo, Rebecca; Gartland, Deirdre; Woolhouse, Hannah; Brown, Stephanie

2015-02-01

fatigue and depressive symptoms are common among women in the postpartum period, and it has been proposed that fatigue is a risk factor for later depression. To progress this research, there is a need to clarify the conceptual and measurement issue of whether these two sets of symptoms are distinct constructs. There is also a need to determine whether they are distinct constructs beyond the postnatal period. The aim of the study was to assess the construct and discriminant validity of fatigue and depressive symptoms as measured by the SF-36 Vitality subscale (SF-36) and the Edinburgh Postnatal Depression Scale (EPDS) at six months and at four years post partum. data from over 1000 women participating in the Maternal Health Study, a longitudinal study of women׳s physical and psychological health and recovery after childbirth were used. confirmatory factor analysis revealed a two-factor model of fatigue and depressive symptoms represented as distinct but related constructs was a better fit to the data than a one-factor model of fatigue and depression sharing the same underlying construct at both six months and four years post partum. this study provides empirical evidence that maternal fatigue and depression in the first year after having a baby and at four years post partum are best understood as separate psychological constructs or experiences. The findings have important implications for clinical practice, in particular underlining the importance of differentiating tiredness from depression. Copyright © 2014 Elsevier Ltd. All rights reserved.

78 FR 5346 - Approval and Promulgation of Air Quality Implementation Plans; Massachusetts and New Hampshire...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

...-FRL-9754-7] Approval and Promulgation of Air Quality Implementation Plans; Massachusetts and New... (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve State Implementation Plan (SIP... repair network for an on-board diagnostic (OBD2) testing program for model year 1996 and newer vehicles...

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to.... (b) Each application must include the following for each container: (1) Date and place of manufacture...

49 CFR 451.1 - Application for approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.1 Application for approval. (a) Any owner of an existing container may apply for approval to.... (b) Each application must include the following for each container: (1) Date and place of manufacture...

18 CFR 300.21 - Final confirmation and approval.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Final confirmation and approval. 300.21 Section 300.21 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... reasonable number of years after first meeting the Administrator's other costs. (ii) The rates must be based...

18 CFR 300.21 - Final confirmation and approval.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Final confirmation and approval. 300.21 Section 300.21 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... reasonable number of years after first meeting the Administrator's other costs. (ii) The rates must be based...

Metabolic syndrome of weight change from pre-pregnancy to 1–5 years post-partum among Chinese women with prior gestational diabetes

PubMed Central

Li, W.; Liu, H.; Qiao, Y.; Lv, F.; Zhang, S.; Wang, L.; Leng, J.; Liu, H.; Qi, L.; Tuomilehto, J.; Hu, G.

2015-01-01

Aims Few studies have evaluated the effect of weight change from pre-pregnancy to post partum with the risk of cardiometabolic diseases among women with a history of gestational diabetes mellitus. The aim of this study was to evaluate the association between weight change from pre-pregnancy to 1–5 years post partum with metabolic syndrome among Chinese women with prior gestational diabetes mellitus. Methods We performed a retrospective cohort study in 1263 women with gestational diabetes mellitus at 1–5 years post partum. Participants were divided into four groups based on their weight change from pre-pregnancy to 1–5 years post partum: loss of ≥ 3 kg, ± 3 kg, gain of 3–7 kg and gain of ≥7 kg. Results The prevalence of metabolic syndrome was 12.1%, 16.2%, 26.0% and 44.3% among women with weight loss ≥ 3 kg, stable weight (± 3 kg), weight gain 3–7 kg and weight gain ≥ 7 kg from pre-pregnancy to post partum, respectively. The positive association between weight change and metabolic syndrome was observed among women with pre-pregnancy normal weight (BMI < 24 kg/m2), overweight (BMI 24–27.9 kg/m2) and obesity (BMI ≥ 28 kg/m2). The prevalence of metabolic syndrome was almost similar among pre-pregnancy normal weight women with weight gain ≥ 7 kg, pre-pregnancy overweight women with stable weight (± 3 kg) and pre-pregnancy obese women with weight loss ≥3 kg from pre-pregnancy to post partum (P = 0.62). Conclusions Women with gestational diabetes mellitus who had large weight gain from pre-pregnancy to post partum were more likely to develop metabolic syndrome. Women who are pre-pregnancy overweight/obesity and also diagnosed as gestational diabetes mellitus during pregnancy need more weight control after delivery. PMID:25962467

A comparison of the immune response between early exposed and 1 year post exposure to Bacillus anthracis in Indonesia

NASA Astrophysics Data System (ADS)

Redhono, D.; Kusumawardani, A.; Dirgahayu, P.

2018-03-01

Anthrax is one of the zoonotic diseases that usually affects animals and can be transmitted to humans. Immune response of the body during an infection is the presence of antibodies as an effort to defend the body and it will survive for some time in the blood. The aim study is to find out how the initial response to the formation of antibodies and how these antibodies survive after one year. This study is cohort to people exposed to anthrax and found 130 people exposed to anthrax. The most risk factor was direct contact and consumed infected animal meat, which was 34.6%. Clinical manifestations of the skin were 12.3% and all respondents showed positive IgG. While 87.7% did not show any anthrax symptoms. IgG serum examination after 1 year of exposure to anthrax obtained 3.8% still detected antibodies in the body. The relationship between IgG titers with clinical manifestations of anthrax at one year post-outbreak is highly significant p 0.028. In conclusion a significant association between the clinical manifestation with antibody serum anthrax and it still detected after one-year post outbreaks of anthrax.

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

40 CFR 52.1972 - Approval status.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment and...

40 CFR 52.1972 - Approval status.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment and...

40 CFR 52.1972 - Approval status.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment and...

40 CFR 52.1972 - Approval status.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oregon § 52.1972 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oregon's plan for the attainment and...

40 CFR 52.1223 - Approval status.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment and...

40 CFR 52.1223 - Approval status.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment and...

40 CFR 52.1223 - Approval status.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment and...

40 CFR 52.1223 - Approval status.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment and...

40 CFR 52.1223 - Approval status.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment and...

40 CFR 52.2722 - Approval status.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Puerto Rico § 52.2722 Approval status. With the exceptions set forth in this subpart, the Administrator approves Puerto Rico's plans for the...

40 CFR 52.2722 - Approval status.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Puerto Rico § 52.2722 Approval status. With the exceptions set forth in this subpart, the Administrator approves Puerto Rico's plans for the...

40 CFR 52.2722 - Approval status.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Puerto Rico § 52.2722 Approval status. With the exceptions set forth in this subpart, the Administrator approves Puerto Rico's plans for the...

Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel.

PubMed

Stevens, W Grant; Calobrace, M Bradley; Harrington, Jennifer; Alizadeh, Kaveh; Zeidler, Kamakshi R; d'Incelli, Rosalyn C

2016-04-01

Since approval in March 2012, data on Sientra's (Santa Barbara, CA) silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The 9 year follow-up data support the previously published data confirming the ongoing safety and efficacy of Sientra silicone gel breast implants. The authors provide updated 9 year study data for Sientra's round and shaped silicone gel breast implants. The Core Study is an ongoing 10 year study that enrolled 1788 patients with 3506 Sientra implants across four indications (primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction). For the safety analysis, Kaplan-Meier risk rates were calculated to evaluate postoperative complications, including all breast implant-related adverse effects. For the effectiveness analyses, results were presented through 8 years as patient satisfaction scores were assessed at even years. Through 9 years, the overall risk of capsular contracture was 12.6%. Smooth devices (16.6%, 95% CI, 14.2%, 19.5%) had a statistically significantly higher rate of capsular contracture compared to textured devices (8.0%, 95% CI, 6.2%, 10.4%). Out of the 610 reoperations in 477 patients, over half of all reoperations were due to cosmetic reasons (n = 315; 51.6%). Patient satisfaction remains high through 8 years, with 90% of primary augmentation patients indicating their breast implants look natural and feel soft. The 9-year follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirm the very strong safety profile as well as continued patient satisfaction. 2 Therapeutic. © 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Ear Acupuncture for Post-Operative Pain Associated with Ambulatory Arthroscopic Knee Surgery: A Randomized Controlled Trial

DTIC Science & Technology

2014-01-14

E7(/(3+21(180%(5 ,QFOXGHDUHDFRGH 14 Jan 2014 Final Report Ear acupuncture for post-operative pain associated with ambulatory arthroscopic...DISTRIBUTION A. Approved for public release: distribution unlimited. The purpose of this study is to compare ear acupuncture plus standard therapy versus...3298 Ear Acupuncture for Post-operative Pa111 Assoc1ated With Ambulatory Arthroscopic Knee Surgery A Randomized Controlled Trial ’• V ’’ ’-’ I

40 CFR 52.1673 - Approval status.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New York § 52.1673 Approval status. (a) With the exceptions set forth in this section, the Administrator approves the New York State Implementation...

77 FR 1894 - Approval and Promulgation of Implementation Plans; Georgia; Rome; Fine Particulate Matter 2002...