Safety Surveillance Best Practices Draft
FDA has posted on its Web site a draft document, “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff,” as required by the 21st Century Cures Act. The document was released for comment within the next 60 days.
In an executive summary, FDA says the draft “sets forth risk-based principles by which FDA conducts ongoing postmarket safety surveillance for human drugs and biological products.” The major topics addressed are:
- a multidisciplinary, life-cycle approach to management of drug and biologic safety;
- general considerations that inform the frequency and extent of systematic drug and biologic safety monitoring;
- additional considerations based on specific product types and patient populations;
- safety signal identification based on screening and data mining of the adverse event 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;
- a multidisciplinary comprehensive evaluation of the identified safety signal that integrates the cumulative data gathered from all available sources;
- an assessment of the causal association between the identified adverse event and the product; and
- an overview of regulatory and other actions that can be taken in response to identified safety signals.