FDA In Brief: FDA issues final guidance to address ‘gaming’ by the use of citizen petitions | FDA

FDA In Brief: FDA issues final guidance to address ‘gaming’ by the use of citizen petitions | FDA

FDA In Brief: FDA issues final guidance to address ‘gaming’ by the use of citizen petitions

Today the U.S. Food and Drug Administration issued the final guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act. It seeks to lessen the impact that FDA review of certain citizen petitions may have on any pending approval actions. The approach would help the FDA allocate resources efficiently when addressing petitions that are most likely to present an obstacle to the availability of generic drugs. If a citizen petition is received while a product application is already under review, and if the goal date for that review falls within the next 150 days, the guidance states that the FDA would expect to respond to...

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