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Items: 1 to 20 of 129

1.

IOM urges FDA to be more aggressive in monitoring safety of approved drugs.

Kuehn BM.

JAMA. 2012 Jun 20;307(23):2475-6. doi: 10.1001/jama.2012.5993. No abstract available.

PMID:
22797430
2.

The balance of benefit and safety of rosiglitazone: important lessons for our system of drug development and postmarketing assessment.

Califf RM, Kramer JM.

Pharmacoepidemiol Drug Saf. 2008 Aug;17(8):782-6. doi: 10.1002/pds.1617. No abstract available.

PMID:
18655016
3.

The rosiglitazone story--lessons from an FDA Advisory Committee meeting.

Rosen CJ.

N Engl J Med. 2007 Aug 30;357(9):844-6. Epub 2007 Aug 8. No abstract available.

PMID:
17687124
4.

The long Avandia endgame.

Mullard A.

Lancet. 2011 Jul 9;378(9786):113. No abstract available.

PMID:
21748869
5.

The FDA in 2006: reasons for optimism.

Chabner BA, Roberts TG.

Oncologist. 2007 Mar;12(3):247-9. No abstract available.

6.

A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report.

Psaty BM, Meslin EM, Breckenridge A.

JAMA. 2012 Jun 20;307(23):2491-2. doi: 10.1001/jama.2012.5545. No abstract available.

PMID:
22563032
7.

FDA panel advises easing restrictions on rosiglitazone.

Tucker ME.

BMJ. 2013 Jun 10;346:f3769. doi: 10.1136/bmj.f3769. No abstract available.

PMID:
23752055
8.

Congress responds to the IOM drug safety report--in full.

Psaty BM, Korn D.

JAMA. 2007 Nov 14;298(18):2185-7. No abstract available.

PMID:
18000202
9.

Sidelining safety--the FDA's inadequate response to the IOM.

Smith SW.

N Engl J Med. 2007 Sep 6;357(10):960-3. No abstract available.

10.

After Avandia, some seek split in drug approval and monitoring.

Dolgin E.

Nat Med. 2010 Aug;16(8):831. doi: 10.1038/nm0810-831. No abstract available.

PMID:
20689527
11.

IOM advises FDA on ethics in postmarket safety trials.

Kuehn BM.

JAMA. 2010 Aug 11;304(6):627. doi: 10.1001/jama.2010.1080. No abstract available.

PMID:
20699450
12.

FDA committee urges tight restrictions on rosiglitazone.

Roehr B.

BMJ. 2010 Jul 16;341:c3862. doi: 10.1136/bmj.c3862. No abstract available.

PMID:
20639290
13.

Critics press FDA to act on evidence of rosiglitazone's cardiac safety issues.

Mitka M.

JAMA. 2010 Jun 16;303(23):2341-2. doi: 10.1001/jama.2010.788. No abstract available.

PMID:
20551399
14.

IOM panel hears concerns about U.S. drug safety system.

Young D.

Am J Health Syst Pharm. 2005 Jul 15;62(14):1428, 1430-31. No abstract available.

PMID:
15998915
15.

FDA drug-review, surveillance processes under scrutiny.

Miller JL.

Am J Health Syst Pharm. 1999 Mar 1;56(5):404, 406, 408. No abstract available.

PMID:
10096696
16.

Institute of Medicine, Congress seek solutions to FDA's safety woes through reform, funding.

Finkelstein JB.

J Natl Cancer Inst. 2007 Jan 17;99(2):104-7. No abstract available.

PMID:
17227990
17.

Remarks of the Acting FDA Commissioner: FDLI's 48th annual conference.

Crawford LM.

Food Drug Law J. 2005;60(2):99-102. No abstract available.

PMID:
16097087
18.

Ethical considerations in studying drug safety--the Institute of Medicine report.

Mello MM, Goodman SN, Faden RR.

N Engl J Med. 2012 Sep 6;367(10):959-64. doi: 10.1056/NEJMhle1207160. Epub 2012 Aug 22. No abstract available.

19.

The report by the Institute of Medicine and postmarketing surveillance.

Klein DF.

Arch Gen Psychiatry. 1999 Apr;56(4):353-4. No abstract available.

PMID:
10197831
20.

IOM outlines framework for postmarket safety.

Reinke T.

Manag Care. 2012 Aug;21(8):10-1. No abstract available.

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