New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints
27 oktober 2009
Before approving a drug, the Food and Drug Administration (FDA) assesses a drug's effectiveness. (...) Concerns have been raised about FDA's reliance on surrogate endpoints and its oversight of postmarketing studies.
Bron: US Government Accountability Office (GAO), zie ook het volledige rapport onder Publicaties
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