Guidance on Clinical Safety Review of a New Application
02/18/2005
Federal Register Notice: FDA is making available a review 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 a safety component of a new drug or biologic product application’s clinical review 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. To download this guidance, click here. To view this notice, click here.
