[DOWNLOAD] "Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition)" by The Law Library " eBook PDF Kindle ePub Free
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