Editorial

Hospital Pharmacy

Volumn 44, Issue 3, 2009, Pages 208-209

  Baker, Danial E ^a  

^a WASHINGTON STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

DRUG APPROVAL; DRUG MONITORING; DRUG SAFETY; EDITORIAL; FOOD AND DRUG ADMINISTRATION; RISK ASSESSMENT;

EID: 62949216514     PISSN: 00185787     EISSN: None     Source Type: Journal    
DOI: 10.1310/hpj4403-208     Document Type: Editorial

References (7)

1. Lee LY, Kortepeter CM, Willy ME, Nourjah P. Drug-risk communication to pharmacists: assessing the impact of risk- minimization strategies on the practice of pharmacy. J Am Pharm Assoc (2003). 2008;48(4):494-500.
2. Questions and answers on the Federal Register notice on drugs and biological products deemed to have risk evaluation and mitigation strategies. US Food and Drug Administration Web site. www.fda.gov/cder/regulatory/FDAAA/FR-QA. htm. Updated March 27, 2008. Accessed January 11, 2009.
3. Office of Surveillance and Epidemiology; US Food and Drug Administration. An overview of RiskMAPs. www.docstoc.com/docs/573628/An-Overview-of-RiskMAPs. Published June 25, 2007. Accessed January 10, 2009.
4. Post-approval frequently asked questions (FAQ). Pharmaceutical Product Development, Inc, Web site. www.ppdi.com/services/post-approval/faq.ht m. Published 2009. Accessed January 11, 2009.
5. Segligman PJ. FDA Amendments Act (FDAAA): New regulatory authorities [presentation]. Paper presented at: Royal Danish Embassy Conference; November 4, 2008; Copenhagen, Denmark. www.ambwashington.um.dk/NR/rdonlyres/60B9CA25-FF37- 4B89-93D7-959D9F9F24BB/0/915FDAAmendments ActandNewRegulatoryAuthorityPaulSelig man.ppt. Accessed January 10, 2009.
6. Jenkins J, Dal Pan G. Memorandum of agreement between the Office of New Drugs and the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research. US Food and Drug Administration Web site. www.fda.gov/cder/drug/DrugSafety/OSE-OND-MOA.pdf. Published October 15, 2008. Accessed January 11, 2009.
7. Approved risk evaluation and mitigation strategies (REMS). US Food and Drug Administration. www.fda.gov/cder/drug/DrugSafety/REMS.htm. Published October 28, 2008. Accessed January 11, 2009.