US FDA Details Facilities That NDAs, ANDAs Should Note

 
• By Joanne S. Eglovitch

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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FDA Clarifies Who Must Be Listed As Manufacturing Facilities • Source: Shutterstock

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