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New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments

 
• By Derrick Gingery

Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.

technology upgrade
As the new director of the Office of Strategic Programs, Sri Mantha will help with the center's IT modernization. • Source: Shutterstock

Bioequivalence assessors in the US Food and Drug Administration’s Office of Generic Drugs are scrapping the decades-old narrative review for a new tool that streamlines the process.

The Generic Drug Structured Assessment for Bioequivalence (GDSA-BE) now is being used for two-way crossover in vivo pharmacokinetic BE studies...

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The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

More from Biosimilars & Generics

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

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The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

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