USA – Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff : Draft Guidance

Executive Summary

This document, Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff, sets forth risk-based principles by which the Food and Drug Administration (FDA or Agency) conducts ongoing postmarketing safety surveillance for human drug and biological products (biologics). The main topics this document addresses include:
• A multidisciplinary, life-cycle approach to the management of drug and biologic safety.
• General considerations that inform the frequency and extent of systematic drug and biologic safety monitoring (section 4).
• Additional considerations based on specific product types and patient populations (section 5).
• Safety signal identification based on screening and data mining of the adverse event (AE)
reporting system and other data sources, including general practices for the frequency and extent of screening these data sources, as well as prioritizing identified signals (section 6).
• A multidisciplinary, comprehensive evaluation of the identified safety signal that integrates the cumulative data gathered from all available sources (section 7).
• An assessment of the causal association between the identified AE and the product (section 8).
• An overview of regulatory and other actions that can be taken in response to identified safety signals (section 9)…