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

American Journal of Health-System Pharmacy

Volumn 66, Issue SUPPL. 7, 2009, Pages

  Meyer, Brian M ^a  

^a AMERICAN SOCIETY OF HEALTH SYSTEM PHARMACISTS   (United States)

Author keywords

Food and drug administration (U.S.); Pharmacists, hospital; Pharmacy, institutional, hospital; Postmarketing surveillance; Regulations; Risk management; Toxicity

Indexed keywords

ADVERSE OUTCOME; CERTIFICATION; CONFERENCE PAPER; DRUG APPROVAL; DRUG MANUFACTURE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE SYSTEM; LAW; PHARMACIST; PHARMACY; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PRIORITY JOURNAL; RISK EVALUATION AND MITIGATION STRATEGY; RISK MANAGEMENT; STANDARDIZATION;

EID: 74049096156     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.2146/ajhp090460     Document Type: Conference Paper

References (7)

1. 110th U.S. Congress. Food and Drug Administration Amendments Act of 2007. http://frwebgate.access.gpo.gov/cgi-bin/ getdoc.cgi?dbname= 110-cong-public- laws&docid=f:publ085.110 (accessed 2009 Jun 11).
2. U.S. Food and Drug Administration. Prescription Drug User Fee Act (PDUFA). http://www.fda.gov/ForIndustry/User-Fees/PrescriptionDrugUserFee/ default. htm (accessed 2009 Jun 17).
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5. U.S. Food and Drug Administration. The Sentinel Initiative: a national strategy for monitoring medical product safety. http://www.fda.gov/Safety/ FDAsSentinel Initiative/ucm089474.htm (accessed 2009 Jun 11).
6. U.S. Food and Drug Administration. Sec. 505-1. [21 USC §355-1] Risk evaluation and mitigation strategies, http:// www.fda.gov/RegulatoryInformation/ Legislation/FederalFoodDrugand CosmeticActFDCAct/FDCActChapter VDrugsandDevices/ucm109090.htm (accessed 2009 Jun 11).
7. U.S. Food and Drug Administration. Risk evaluation and mitigation strategies for certain opioid drugs; notice of public hearing. April 20, 2009. http://www.fda. gov/OHRMS/DOCKETS/98fr/E9-8992. pdf (accessed 2009 Jun 11).