The Law Library

Food and Drug Administration Review and Action on Over-The-Counter Time and Extent Applications (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) The Law Library

Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements 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). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient. This book contains: - The complete text of the Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section