US FDA’s Drug Shortage Program On ‘Site Engagement’ To Be Nixed In GDUFA III

Generics industry and FDA also debated inspection policies in lieu of travel and safety restrictions mandated by the pandemic.

Pharmaceutical manufacturing line
Facility inspections remained a discussion topic during GDUFA III negotiations in April. • Source: Alamy

A voluntary US Food and Drug Administration program intended to help manufacturers prevent product shortages will not survive the upcoming generic drug user fee reauthorization.

FDA and industry representatives agreed during a 22 April GDUFA III negotiating session “to not move forward with the Site...

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