Risk management of drug products and the U.S. Food and Drug Administration: Evolution and context

Author:

Leiderman Deborah B.

Publisher

Elsevier BV

Subject

Pharmacology (medical),Psychiatry and Mental health,Pharmacology,Toxicology

Reference20 articles.

1. Drug Enforcement Administration, 2008. Prescription Drug Monitoring Programs. http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm (accessed December 12, 2008).

2. European Medicines Agency, 2005. Guideline on Risk Management Systems for Medicinal Products for Human Use. EMEA http://www.emea.europa.eu/pdfs/human/euleg/9626805en.pdf (accessed December 12, 2008).

3. Food and Drug Administration, 1998. Actiq Approval Letter. http://www.fda.gov/Cder/foi/appletter/1998/20747ltr.pdf (accessed December 12, 2008).

4. Food and Drug Administration, 2002a. Xyrem (sodium oxybate): Questions and Answers. http://www.fda.gov/cder/drug/infopage/xyrem/xyrem_qa.htm (accessed December 11, 2008).

5. Food and Drug Administration, 2002b. Lotronex (alosetron hydrochloride) Information. FDA http://www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm (accessed December 12, 2008).

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