federal_register: 2016-07612

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2016-07612 Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications Proposed Rule The Food and Drug Administration (FDA or Agency) is proposing to amend its nonprescription (over-the-counter or OTC) drug regulations. The proposed rule, if finalized as proposed, would supplement the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). We are also proposing other changes to make the TEA process more efficient. 2016-04-04 2016 4 https://www.federalregister.gov/documents/2016/04/04/2016-07612/food-and-drug-administration-review-and-action-on-over-the-counter-time-and-extent-applications https://www.govinfo.gov/content/pkg/FR-2016-04-04/pdf/2016-07612.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is proposing to amend its nonprescription (over-the-counter or OTC) drug regulations. The proposed rule, if finalized as proposed, would supplement the time and extent application (TEA) process for OTC...

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