Drugs
-
Drug Safety
Below is a sortable table of Drug Safety Guidances
Note:Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (PDF - 1516KB)
This guidance has been superseded by
Attachment B: Clinical Safety Review of an NDA or BLA of the Good Review Practice: Clinical Review Template (MAPP 6010.3 Rev. 1) that was posted on Dec 15, 2010
-
-
-
-