Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance

OMB 0910-0701

OMB 0910-0701

This information collection supports agency guidance that includes FDA recommendations on adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. The purpose of the information collection is to help support global preparedness in the event of such a pandemic and help offset associated threats and risks to the public health.

The latest form for Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance expires 2021-05-31 and can be found here.

OMB Details

Notify FDA When Normal Reporting is Not Feasible

Federal Enterprise Architecture: Health - Public Health Monitoring


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