Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic." The guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. The Agency makes recommendations to industry for focusing limited resources on reports related to products indicated for the prevention and treatment of influenza and other specific types of reports indicated in the guidance.