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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing
Today the FDA announced a new prioritization pilot program for ANDAs that aims to spur and reward investment in U.S. drug manufacturing and research and development and strengthen the domestic pharmaceutical supply chain by providing faster reviews for generic companies who test and manufacture their products in the U.S.
Earlier this week, FDA hosted a public meeting titled “Onshoring Manufacturing of Drugs and Biological Products” on FDA’s PreCheck program, which introduces an innovative two-phase approach to accelerate the establishment of high priority new pharmaceutical manufacturing facilities in the U.S. and strengthen the domestic pharmaceutical supply chain. At that meeting, FDA heard from stakeholders about how incentives such as faster reviews could spur additional investment in U.S. manufacturing and research and development.
This ANDA prioritization pilot represents a further step FDA is taking to incentivize U.S. generic drug manufacturing and testing. Under this pilot, ANDA applicants who conduct any required bioequivalence testing in the United States and whose products are made in the U.S. using exclusively domestic sources for APIs are eligible for priority review. Further information is available at our website: FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing. Prioritizing this additional category of ANDAs is expected to expedite the availability of high-quality, U.S.-made generics for American consumers.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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