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

 
• By Derrick Gingery

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 Engagement Program,” according to

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