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Items: 1 to 20 of 121

1.

Prepare for the long haul of drug monitoring.

Gliklich R.

Nat Med. 2010 Aug;16(8):848. doi: 10.1038/nm0810-848. No abstract available.

PMID:
20689542
2.

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
3.

Comparative regulation of drug and aircraft development: lessons for regulatory reform?

Urquhart J.

Clin Pharmacol Ther. 1997 Dec;62(6):583-6. No abstract available.

PMID:
9433385
4.

FDA attempting to overcome major roadblocks in monitoring drug safety.

Zielinski SL.

J Natl Cancer Inst. 2005 Jun 15;97(12):872-3. No abstract available.

PMID:
15956645
5.

Monitoring drug product quality.

Bolger G, Goetsch R, Reinstein P.

Am Pharm. 1992 Feb;NS32(2):47-9. No abstract available. Erratum in: Am Pharm 1992 Apr;NS32(4):6.

PMID:
1546630
6.

FDA's monitoring of postmarketing studies probed.

Young D.

Am J Health Syst Pharm. 2006 Aug 15;63(16):1485-6. No abstract available.

PMID:
16896075
7.

The Food and Drug Administration Amendments Act of 2007: drug safety and health-system pharmacy implications: introduction.

Shane R.

Am J Health Syst Pharm. 2009 Dec 15;66(24 Suppl 7):S2-3. doi: 10.2146/ajhp090459. No abstract available.

PMID:
19966076
8.

Evaluating drug effects in the post-Vioxx world: there must be a better way.

Avorn J.

Circulation. 2006 May 9;113(18):2173-6. No abstract available.

9.

The Food and Drug Administration's use of postmarketing (Phase IV) study requirements: exception to the rule?

Steenburg C.

Food Drug Law J. 2006;61(2):295-383. No abstract available.

PMID:
16903034
10.
11.

Reforms on drug safety.

[No authors listed]

Nature. 2006 Sep 28;443(7110):372. No abstract available.

PMID:
17006474
12.

Canadian and US drug approval times and safety considerations.

Rawson NS, Kaitin KI.

Ann Pharmacother. 2003 Oct;37(10):1403-8.

PMID:
14519031
13.

Industry reneges on postmarketing trial commitments.

Bouchie A.

Nat Biotechnol. 2003 Jul;21(7):718. No abstract available.

PMID:
12833074
15.

FDA's first active medical product surveillance eyes antidiabetic-MI link.

Thompson CA.

Am J Health Syst Pharm. 2011 Apr 1;68(7):550-1. doi: 10.2146/news110018. No abstract available.

PMID:
21411791
16.

The Vioxx debacle.

Fielder JH.

IEEE Eng Med Biol Mag. 2005 Mar-Apr;24(2):106-9. No abstract available.

PMID:
15825852
17.

Making medicines safer--the need for an independent drug safety board.

Wood AJ, Stein CM, Woosley R.

N Engl J Med. 1998 Dec 17;339(25):1851-4. No abstract available.

PMID:
9854125
18.

The complexity of integrating speed and safety in drug development and approval.

Charo RA.

JAMA Intern Med. 2013 Jul 8;173(13):1165-6. doi: 10.1001/jamainternmed.2013.7161. No abstract available.

PMID:
23568604
19.

The unfinished business of U.S. drug safety regulation.

Evans BJ, Flockhart DA.

Food Drug Law J. 2006;61(1):45-63. No abstract available.

PMID:
16838457
20.

StatBite. FDA-required postmarketing studies, 1992-2008.

[No authors listed]

J Natl Cancer Inst. 2010 Sep 8;102(17):1303. doi: 10.1093/jnci/djq340. Epub 2010 Aug 25. No abstract available.

PMID:
20739654

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