Regulatory Considerations for Determining Postmarketing Study Commitments

Postmarketing Study Commitments (PMCs) are, most commonly, agreements made by pharmaceutical companies at the time of an FDA approval to perform a study or studies to elucidate further characteristics of the drug under consideration. The role of PMCs in drug regulation has come under considerable sc...

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Veröffentlicht in:	Clinical pharmacology and therapeutics 2007-08, Vol.82 (2), p.228-230
1. Verfasser:	Meyer, R J
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Biological and medical sciences Drug Approval - legislation & jurisprudence Drug Approval - methods Humans Legislation, Drug Medical sciences Pharmacology. Drug treatments Product Surveillance, Postmarketing - methods Product Surveillance, Postmarketing - standards Public Policy United States United States Food and Drug Administration
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