The US Food and Drug Administration (FDA) has finalized a guidance describing best practices for its staff in conducting postmarketing safety surveillance of marketed drug and biological products.
This document was published under a mandate of the 21st Century Cures Act, which required FDA to publish these best practices on its website. The document replaces a previous requirement under the Food and Drug Administration Amendments of 2007 (FDAAA) that FDA prepare a safety summary analyses of the adverse drug reports received for a drug by 18 months after approval or after use of the drug in 10,000 individuals, whichever is later…
