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This bill amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to use the least burdensome appropriate means when evaluating requests to establish over-the-counter monograph drugs as generally recognized as safe and effective. The bill requires the FDA to meet with requestors if published reports are insufficient to support findings, provide recommendations on types of evidence needed, and document meeting minutes and study parameters in the administrative record. The bill does not alter the criteria for determining whether a drug is safe and effective or whether a request is sufficiently complete for review.
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