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 A draft guidance calls for normal adverse event reporting to continue up to and including Response Stage 4 of an influenza pandemic.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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