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GDUFA III May Be Opportunity For Proactive Pharmacovigilance Discussions

 
• By Derrick Gingery

Generics sponsors want FDA input before making decisions on pharmacovigilance problems, potentially adding another topic to user fee discussions.

Blister Packs
FDA and sponsors may be interested in increasing communications related to generic drug pharmacovigilance activities. • Source: Shutterstock

Generic drug sponsors may need more opportunities to proactively discuss pharmacovigilance-related issues with the US Food and Drug Administration, adding another issue to the list of potential topics for the upcoming user fee program reauthorization.

When quality or other issues arise after a generic product reaches the market, sponsors often cannot discuss resolution ideas with

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