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FDA Guides On Generic Product-Specific Meetings, Under GDUFA III Commitment

PSG Teleconferences, Pre-Submission And Post-Submission Meetings In Draft Guide

 
• By Dean Rudge

With GDUFA III now almost at the five-month stage, the FDA has released draft guidance on product-specific guidance (PSG) meetings between FDA and a prospective applicant, as part of commitments set forth under the Generic Drug User Fee Act.

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Recommendations for industry on product-specific guidance (PSG) meetings under the third iteration of the Generic Drug User Fee Act, GDUFA III, have been outlined in draft guidance published by the US Food and Drug Administration.

The proposals, coming just under five months after GDUFA was reauthorized, are intended to provide procedures that will promote “well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in

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