Are Risk Evaluation and Mitigation Strategies Associated With Less Off-Label Use of Medications? The Case of Immune Thrombocytopenia-Reference-Cited by-同舟云学术

Are Risk Evaluation and Mitigation Strategies Associated With Less Off-Label Use of Medications? The Case of Immune Thrombocytopenia

Published:2014-12-20 Issue:2 Volume:97 Page:186-193
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Sarpatwari A¹,Franklin JM¹,Avorn J¹,Seeger JD¹,Landon JE¹,Kesselheim AS¹

Affiliation:

1. Program On Regulation; Therapeutics; And Law (PORTAL); Division of Pharmacoepidemiology and Pharmacoeconomics; Department of Medicine; Brigham and Women's Hospital and Harvard Medical School; Boston Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference48 articles.

1. US Food and Drug Administration Amendments Act, Pub. L. No. 110-85, 121 Stat. 823 2007

2. US Food and Drug Administration Approved risk evaluation mitigation strategies http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111350.htm 2014

3. Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation;Banerjee;Drug Saf.,2014

4. Pharmacy groups want to change the FDA's REMS authority: battles loom as Congress aims to pass a major bill by September 2012;Barlas;P. & T.,2012

5. Gaffney , A. Prometheus slams FDA for lack of REMS clarity as agency shows signs of conceding. Regulatory Focus http://www.raps.org/regulatoryDetail.aspx?id=8584 2013

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