The FDA issued a draft guidance discussing its approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during the “Federal Government Response Stages” of an influenza pandemic, as defined by the Homeland Security Council. The FDA anticipates that during an influenza pandemic, industry and FDA workforces may be reduced while reporting of adverse events related to widespread use of influenza-related products may increase. The draft guidance titled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” makes recommendations to industry for focusing limited resources on reports related to influenza-related products and other specific types of reports. The draft guidance indicates the FDA's intention not to object if, during Federal Government Response Stage 5, certain required adverse event reports are not provided within the timeframes required by statute and regulation, as long as any delayed reports are then provided during Federal Government Response Stage 6.
SOURCE: FDA Guidance.
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