Effectiveness of risk management plans: a case study of pemoline using pharmacy claims data

Author:

Morrato Elaine H.,Staffa Judy A.

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference52 articles.

1. U.S. Food and Drug Administration. FDA Improvements in Drug Safety Monitoring. Available at: http://www.fda.gov/oc/factsheets/drugsafety.html, 2/27/05.

2. U.S. Food and Drug Administration. Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Available at: http://www.fda.gov/cber/guidelines.htm#pharma. Accessed April 6, 2005.

3. U.S. Food and Drug Administration. Guidance for Industry: Development and Use of Risk Minimization Action Plans. Available at: http://www.fda.gov/cder/guidelines.htm#minim. Accessed April 6, 2005.

4. The role of databases in drug postmarketing surveillance

5. Cylert® (pemoline) package insert. Physicians' Desk Reference. (59th edn). Thomson PDR: Montvale, NJ, 2005. 418–420.

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