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FDA Outlines Criteria For Approving Manufacturing Supplements Under GDUFA

 
• By Joanne S. Eglovitch

Generic drug manufacturers are told by FDA when and how it will accept prior approval supplements under GDUFA.

FDA on Oct. 17 issued final guidance to generic drug applicants explaining its criteria for reviewing and approving prior approval supplements under the Generic Drug User Fee Act. The guidance makes several technical changes from a draft version issued two years ago.

The guidance applies to applicants of abbreviated new drug applications (ANDAs) that electronically submit a prior approval supplement on or after Oct. 1, 2014. The guidance does not apply to...

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