Review of Clinical Safety Data in Marketing Applications; Notice of Public Workshop

Streszczenie

The Food and Drug Administration (FDA) is announcing a public workshop, as part of its ``good review practices'' (GRP's), to provide an opportunity for input from the pharmaceutical industry, academia, and the public on the principles and methods being used by FDA in the review of clinical safety data in new drug product applications. Information and ideas generated at the workshop will be used to develop a guidance for reviewers who participate in the agency's clinical review process. A working draft of that guidance, ``Draft Guidance for Reviewers: Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review,'' along with a tentative workshop agenda, will be available 3 weeks before the workshop.