US food and drug administration and design of drug approval studies

JAMA - Journal of the American Medical Association

Volumn 312, Issue 20, 2014, Pages 2163-2165

  Woloshin, Steven ^a   Schwartz, Lisa M ^a   Frankel, Brittney ^b   Faerber, Adrienne ^a  

^a DARTMOUTH INSTITUTE FOR HEALTH POLICY AND CLINICAL PRACTICE   (United States)

^b WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

DATA ANALYSIS; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; LETTER; MEDICAL RESEARCH; METHODOLOGY; OUTCOME ASSESSMENT; PROTOCOL COMPLIANCE; QUALITY CONTROL; UNITED STATES; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); INTERPERSONAL COMMUNICATION; PROCEDURES;

CLINICAL PROTOCOLS; CLINICAL TRIALS AS TOPIC; COMMUNICATION; DRUG APPROVAL; DRUG INDUSTRY; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84914164546     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2014.13329     Document Type: Letter

References (6)

1. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients. Fed Regist. 1998;63 (231):66631-66672.
2. US Department of Health and Human Services; US Food and Drug Administration. Guidance for industry: special protocol assessment. http://www.fda.gov/downloads/Drugs/Guidances/ucm080571.pdf. Accessed May 8,2014).
3. US Food and Drug Administration. Drugs@FDA: FDA approved drug products. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/Accessed June 23, 2014.
4. Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category-implications for patients. N Engl J Med. 2014;370(13):1252-1258.
5. US Food and Drug Administration. Independent evaluation of FDA's first cycle review performance-retrospective analysis: final report text. Accessed May 9, 2014. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119469.htm).
6. Sacks L, Shamsuddin H, Yasinskaya Y, Bouri K, Lanthier M, Sherman R. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012. JAMA. 2014;311(4):378-984.