Home » How Much Power do Drugmakers Have to Challenge Changes?
How Much Power do Drugmakers Have to Challenge Changes?
Once the FDA makes a determination that new safety information needs to be added under the FD&C Act section 505(o)(4), the agency sends a safety labeling change notification letter to the application holder(s).
The Food & Drug Letter
The Food & Drug Letter
Upcoming Events
-
04Apr
-
11Apr
-
14Apr
-
25Apr
-
14May