Reviewer Guidance on Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a reviewer guidance entitled "Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review." The guidance is intended to provide an annotated outline of the safety component of a clinical review of a new drug or biologic product application and guidance on how to conduct and organize the safety review. The guidance is also intended to provide standardization and consistency in the format, content, and quality of safety reviews. This reviewer guidance has been developed as part of the agency's good review practices initiative.