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Home » FDA RELEASES CRITICAL ICH DRAFT GUIDANCE ON PHARMACOVIGILANCE
FDA RELEASES CRITICAL ICH DRAFT GUIDANCE ON PHARMACOVIGILANCE
April 2, 2004
The FDA has released an International Conference on Harmonisation (ICH) pharmacovigilance draft guidance that outlines ways drugmakers can summarize the identified risks of a drug, the potential for unidentified risks, possible at-risk populations, and situations that have not been studied preapproval.