The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

JAMA - Journal of the American Medical Association

Volumn 318, Issue 21, 2017, Pages 2137-2138

  Hwang, Thomas J ^a   Darrow, Jonathan J ^a   Kesselheim, Aaron S ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL DEVELOPMENT TIME; CLINICAL STUDY; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG THERAPY; FOOD AND DRUG ADMINISTRATION; LETTER; PRACTICE GUIDELINE; PRIORITY JOURNAL; TIME; STATISTICS AND NUMERICAL DATA; TIME FACTOR; UNITED STATES;

DRUG APPROVAL; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85038357461     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2017.14896     Document Type: Letter

References (5)

1. US Food and Drug Administration. Guidance for industry: expedited programs for serious conditions-drugs and biologics. https://www.fda.gov /downloads/drugs/guidancecomplianceregulatoryinformation/guidances /ucm358301.pdf. Accessed August 17, 2017.
2. US Food and Drug Administration. Novel drug approvals for 2016. https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation /ucm483775.htm. Accessed August 17, 2017.
3. Downing NS, Shah ND, Aminawung JA, et al. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA. 2017;317(18):1854-1863.
4. Kesselheim AS, Woloshin S, EddingsW, Franklin JM, Ross KM, Schwartz LM. Physicians' knowledge about FDA approval standards and perceptions of the "breakthrough therapy" designation. JAMA. 2016;315(14):1516-1518.
5. Krishnamurti T, Woloshin S, Schwartz LM, Fischhoff B. A randomized trial testing US Food and Drug Administration "breakthrough" language. JAMA Intern Med. 2015;175(11):1856-1858.