A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: Opportunities provided by a new IOM report

JAMA

Volumn 307, Issue 23, 2012, Pages 2491-2492

  Psaty, Bruce M ^a   Meslin, Eric M ^b   Breckenridge, Alasdair ^c  

^a UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^b Indiana University   (United States)

^c MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; PIOGLITAZONE; ROSIGLITAZONE; THALIDOMIDE;

CARDIOVASCULAR RISK; DRUG APPROVAL; DRUG EFFECT; DRUG INFORMATION; DRUG LABELING; DRUG MARKETING; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GLUCOSE BLOOD LEVEL; HUMAN; LICENSING; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SAFETY; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SHORT SURVEY;

EID: 84862487910     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2012.5545     Document Type: Short Survey

References (8)

1. Committee on the Assessment of the US Drug Safety System. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Baciu A, Stratton K, Burke SP, eds. Washington, DC: National Academies Press; 2006.
2. Powers A, Cook GE. Potential safety signals and their significance. Arch Intern Med. 2012;172(1):72-73.
3. Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between July-September 2011. FDA website. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ Surveillance/AdverseDrugEffects/ucm281856.htm. Accessed May 2, 2012.
4. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356(24):2457-2471. (Pubitemid 46919772)
5. Food and Drug Administration. Guidance for industry: diabetes mellitus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Center for Drug Evaluation and Research, US Department of Health and Human Services, FDA. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf. December 2008. AccessedMay2, 2012.
6. Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Washington, DC: National Academies Press; 2012. http://www.iom.edu/ Reports/2012/Ethical-and-Scientific-Issues-in-Studying-the-Safety-of-Approved- Drugs.aspx. Posted May 1, 2012. Accessed May 2, 2012.
7. Briesacher BA, Soumerai SB, Zhang F, et al. Methods to evaluate the impact of FDA regulatory actions. Mini-sentinel white paper. http://www.mini-sentinel.org/work-products/Statistical-Methods/ Mini-Sentinel-Methods-Impact-of-FDA-Regulatory-Actions-White-Paper.pdf. March 12, 2012.
8. US Department of Health and Human Services. Advancing regulatory science at FDA: a strategic plan. http://www.fda.gov/downloads/ScienceResearch/ SpecialTopics/RegulatoryScience/UCM268225.pdf. August 2011. Accessed May 2, 2012.