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Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition)

eBook details

Title: Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
Author : The Law Library
Release Date : January 06, 2018
Genre: Law,Books,Professional & Technical,
Pages : * pages
Size : 165 KB

Description

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 ebook 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 dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure