US FDA Details Facilities That NDAs, ANDAs Should Note
The US FDA has made a renewed effort to clarify the types of manufacturing facilities that need to be listed on the Form FDA 356h and Module 3 of the CTD in submissions. Often reviewers find this information missing, whicn can result in a refuse to file action.
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Industry complained draft guidance would have made manufacturing establishment information harder to report, not easier.
Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.