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Expert Analysis

Coming Soon: FDA Over-The-Counter Drug Approval Overhaul

By Rebecca Dandeker, Ann Begley, Kathleen Sanzo and Suzanne Bassett (December 17, 2018, 3:16 PM EST) -- A new pathway for over-the-counter products could be on the horizon, as both houses of Congress have proposed bills to revise the U.S. Food and Drug Administration's procedures to allow OTC medications to be marketed, and to permit the FDA to collect user fees, potentially expediting a newly created OTC drug review process. The FDA is preparing for an eventual passage of the law, and so should OTC drug manufacturers and private label distributors....

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