Best Practices in Drug and Biological Product Postmarket Safety Surveillance for Food and Drug Administration Staff; Draft Document; Availability; Establishment of Public Docket; Request for Comments

Streszczenie

The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on a draft document that details best practices for drug safety surveillance entitled "Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff." The 21st Century Cures Act (Cures Act) was enacted on December 13, 2016, and requires that FDA make publicly available on its internet website best practices for drug safety surveillance activities. The draft document sets forth risk-based principles by which FDA conducts ongoing postmarketing safety surveillance for drug and biological products to address the Cures Act requirements. FDA is seeking public comment on the draft best practices in drug and biological product postmarket safety surveillance.