New drug: Caution indicated

Archives of Internal Medicine

Volumn 172, Issue 21, 2012, Pages 1681-1682

  Moore, Thomas J ^a  

^a INSTITUTE FOR SAFE MEDICATION PRACTICES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

CANADA; DECISION MAKING; DRUG APPROVAL; DRUG EXPOSURE; DRUG INDUSTRY; DRUG MECHANISM; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; IN VITRO STUDY; LAW; LONG TERM CARE; METABOLISM; NOTE; PRIORITY JOURNAL; UNITED STATES;

DRUG APPROVAL; HUMANS; SAFETY;

EID: 84870573488     PISSN: 00039926     EISSN: 15383679     Source Type: Journal    
DOI: 10.1001/2013.jamainternmed.610     Document Type: Note

References (6)

1. Wood AJ. The safety of new medicines: the importance of asking the right questions. JAMA. 1999;281(18):1753-1754. (Pubitemid 29226487)
2. Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? [published online October 8, 2012]. Arch Intern Med. 2012;172(21):1680-1681.
3. Psaty BM, Meslin EM, Breckenridge A. A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report. JAMA. 2012;307(23):2491-2492.
4. Moore TJ, Singh S, Furberg CD. The FDA and new safety warnings. Arch Intern Med. 2012;172(1):78-80.
5. The extent of population exposure to assess clinical safety: for drugs intended for long-term treatment of non-life-threatening conditions, 1995. International Conference on Harmonisation website. http://www.ich.org/products/ guidelines/efficacy/efficacy-single/article/the-extent-of-population-exposure- to-assess-clinical-safety-for-drugs-intended-for-long-term-treatme.html. Accessed August 16, 2012.
6. US Food and Drug Administration. FY2011 Innovative Drug Approvals. Silver Spring, MD: US Food and Drug Administration; November 2011.