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US FDA Transparency Win: Sponsors Know More Product-Specific Guidances Coming, Requests Fall

 
• By Derrick Gingery

After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined.

transparency
Generic drug sponsors use the anticipated PSG list to validate development portfolios. • Source: Shutterstock

Increased transparency seems to have helped the US Food and Drug Administration’s generic drugs program improve communications with sponsors as well as streamline product development.

Product-specific guidances, which offer recommendations for showing bioequivalence to a brand product, are regularly published and revised to help speed...

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