US FDA Expands Options For Product-Specific Guidance Meetings With ANDA Sponsors

 
• By Derrick Gingery

But so far, even broadening the eligibility beyond the GDUFA III commitment has not prompted any generic drug sponsors to request a meeting with FDA staff about issues created by updated or new product-specific guidances. The size of the request package could be one factor.

generic drugs
The background packages that must accompany a PSG teleconference and meeting requests appear extensive. • Source: Shutterstock

US Food and Drug Administration officials expanded the new product-specific guidance meeting process to include more scenarios where generic drug sponsors can be caught in update limbo, but continues to wait for industry to take the offer.

Changing PSGs remain a nagging problem for generic drug sponsors. Often the documents, which describe the bioequivalence data needed to...

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