The majority of expedited investigational new drug safety reports are uninformative

Clinical Cancer Research

Volumn 22, Issue 9, 2016, Pages 2111-2113

  Jarow, Jonathan P ^a   Casak, Sandra ^a   Chuk, Meredith ^a   Ehrlich, Lori A ^a   Khozin, Sean ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ADVERSE OUTCOME; ARTICLE; DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL AUDIT; PRIORITY JOURNAL; PUBLICATION; ONCOLOGY; PROCEDURES; UNITED STATES;

NEW DRUG;

DRUG APPROVAL; DRUGS, INVESTIGATIONAL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; MEDICAL ONCOLOGY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84968571735     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-15-2082     Document Type: Article

References (5)

1. Food and Drug Administration. IND safety reporting, 21 C.F.R., Sect. 312.32.[Cited 2016 February 2]. Available from: http://www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm.
2. Sherman RB, Woodcock J, Norden J, Grandinetti C, Temple RJ. New FDA regulation to improve safety reporting in clinical trials. N Engl J Med 2011;365:3-5.
3. Guidance for industry and investigators: safety reporting requirements for INDs (investigational new drug applications) and BA/BE (bioavailability/ bioequivalence) studies [PDF on the Internet]. Silver Spring, MD: U.S. Food and Drug Administration; 2012 [cited 2015 Nov 23]. Available from: http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf.
4. Wittes J, Crowe B, Chuang-Stein C, Guettner A, Hall D, Jiang Q, et al. The FDA's final rule on expedited safety reporting: statistical considerations. Stat Biopharm Res 2015;7:174-90.
5. Archdeacon P, Grandinetti C, Vega JM, Balderson D, Kramer JM. Optimizing expedited safety reporting for drugs and biologics subject to an investigational new drug application. Ther Innov Regul Sci 2013;48:200-7.