FDA outlines risk-based best practices for conducting ongoing postmarketing safety surveillance activities for drugs and biological products.

Today the U.S. Food and Drug Administration (FDA) posted a draft document on its website titled “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.” This document is required under a provision of the 21st Century Cures Act. The Act includes a revision to a previous statutory requirement that generally required FDA to undertake routine safety analyses of drugs 18 months following approval or after 10,000 individuals have used the drug, whichever occurs later.

Over time, the FDA found these assessments to be largely redundant to FDA’s existing surveillance practices. The assessments also did not provide sufficient flexibility to take a risk-based approach based on various factors, including the characteristics of products or their projected use. For example, many drugs and biological products for rare diseases never met the 10,000-individual use threshold triggering these analyses.

The 21st Century Cures Act replaced the previous 18-month/10,000 patient analyses with a new requirement that FDA make publicly available on the internet its best practices for drug safety surveillance activities for drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed as biological products under section 351 of the Public Health Service Act.

FDA is making this draft best practices document available for comment and encourages interested parties to share their comments with the Agency. The comment period will be open for 60 days and comments can be submitted to the public docket (FDA-2019-N-3768). Following the closure of the comment period, FDA will revise the document as necessary and will post a final version. More information is available in the Federal Register Notice.
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