Best Practices for Food and Drug Administration Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products; Final Document; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final document entitled "Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products." The 21st Century Cures Act (Cures Act), enacted on December 13, 2016, requires that FDA make publicly available on its internet website best practices for certain postmarketing drug safety surveillance activities. This final document sets forth risk-based principles for FDA's conduct of ongoing postmarketing safety surveillance for human drug products and human biological products, in part, to address the Cures Act requirements. This document finalizes the draft document entitled "Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff" that was issued on November 7, 2019.