US FDA revises post-marketing safety provisions

7 November 2019

The US Food and Drug Administration has published a draft document which outlines its methodology for conducting ongoing post-marketing safety surveillance.

Publication of the guidance, which covers both drug and biological products, is mandated by the 21st Century Cures Act.

A previous statutory requirement requiring routine safety analyses of drugs 18 months following approval has been revised under the Act. The FDA said that these assessments were found to be “largely redundant” to existing practices.

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