Advances in regulatory science at the Food and Drug Administration

JAMA

Volumn 309, Issue 20, 2013, Pages 2103-2104

  Psaty, Bruce M ^a,b   Goodman, Steven N ^c   Breckenridge, Alasdair ^d  

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

^b CENTER FOR HEALTH STUDIES   (United States)

^c STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ROSIGLITAZONE;

DRUG APPROVAL; DRUG INFORMATION; DRUG RECALL; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; LIFE CYCLE ASSESSMENT; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SHORT SURVEY; SIDE EFFECT; TOXIC HEPATITIS; UNITED STATES;

EID: 84877937009     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2013.4503     Document Type: Short Survey

References (9)

1. Committee on the Assessment of the US Drug Safety System, Baciu A, Stratton K, Burke SP, eds. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: National Academies Press; 2006.
2. US Food and Drug Administration (FDA). Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Marketing: Draft PDUFA V Implementation Plan-February 2013. FDA website. http://www.fda.gov/downloads/ forindustry/userfees/prescriptiondruguserfee/ucm329758.pdf. Accessed April 5, 2013.
3. European Medicines Agency. Benefit-risk methodology projects. Work package 4 report: benefit-risk tools and processes. European Medicines Agency website. http://www.ema.europa.eu. Accessed March 12, 2013.
4. Schwartz LM, Woloshin S, Welch HG. Using a drug facts box to communicate drug benefits and harms: two randomized trials. Ann Intern Med. 2009;150 (8):516-527.
5. Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Ethical and Scientific Issues in Study the Safety of Approved Drugs. Washington, DC: National Academies Press; 2012.
6. US Food and Drug Administration, Department of Health and Human Services. Report on the performance of drug and biologics firms in conducting postmarketing requirements and commitments. Fed Regist. 2012;77:13339-13343.
7. Psaty BM, Larson EB. Investments in infrastructure for diverse research resources and the health of the public. JAMA. doi:10.1001/jama.2013.3445.
8. Lumpkin MM, Eichler HG, Breckenridge A, Hamburg MA, Lönngren T, Woods K. Advancing the science of medicines regulation: the role of the 21st-century medicines regulator. Clin Pharmacol Ther. 2012;92(4):486-493.
9. Levinson DR; Office of Inspector General. Report (OEI-04-11-00510): FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety. Office of Inspector General website. https://oig.hhs.gov/oei/reports/oei-04-11-00510.asp. February 12, 2013. Accessed April 5, 2013.