Home » FDA Proposes Reporting Leeway During Flu Pandemics
FDA Proposes Reporting Leeway During Flu Pandemics
Drugmakers should develop plans to ensure postmarketing adverse event reports are prepared and submitted regularly during an influenza pandemic, the FDA proposes. A draft guidance calls for normal adverse event reporting to continue up to and including Response Stage 4 of an influenza pandemic. There are six stages in the World Health Organization’s influenza pandemic scale with Stage 6 being a full-blown pandemic.
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