Evidence vs. Access: Can twenty-first-century drug regulation refine the tradeoffs?

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 3, 2012, Pages 378-380

  Woodcock, J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; CORTICOSTEROID; LONG ACTING DRUG; ROSIGLITAZONE;

DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG SAFETY; DRUG UTILIZATION; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HUMAN; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS;

ANIMALS; DRUG APPROVAL; HEALTH SERVICES NEEDS AND DEMAND; HUMANS; LICENSURE;

EID: 84857227370     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.337     Document Type: Review

References (7)

1. Eichler, H.-G. et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91, 426-437 (2012).
2. US Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry: diabetes mellitus-evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes 〈http://www.pharmacy. arizona.edu/sites/default/files/Guidance-for-Industry.pdf〉 (December 2008).
3. US Food and Drug Administration. Endocrinologic and Metabolic Drugs Advisory Committee. Drug Safety and Risk Management Advisory Committee. Advisory Committee Briefing document. Cardiovascular safety of rosiglitazone. Meeting on 13-14 July 2010 〈http://www.fda.gov/downloads/advisorycommittees/ committeesmeeting materials/drugs/endocrinologicandmetabolic drugsadvisorycommittee/ucm218492.pdf〉 (2010).
4. Chowdhury, B.A., Seymour, S.M. & Levenson, M.S. Assessing the safety of adding LABAs to inhaled corticosteroids for treating asthma. N. Engl. J. Med. 364, 2473-2475 (2011).
5. US Food and Drug Administration. FDA's Sentinel Initiative. Transforming how we monitor the safety of FDA-regulated products 〈http://www.fda.gov/ safety/FDAsSentinelInitiative/ucm2007250.htm〉 (May 2008).
6. US Food and Drug Administration. Risk evaluation and mitigation strategy (REMS) public meeting, 27-28 July 2010 〈http://www.fda.gov/drugs/ newsevents/ucm210201.htm〉 (2010).
7. Arrowsmith, J. Trial watch: phase III and submission failures: 2007-2010. Nat. Rev. Drug Discov. 10, 87 (2011).