Latest FDA News

Drug Supply Chain Security Act (DSCSA)

The Drug Quality and Security Act (DQSA) of 2013 -- Law outlines critical steps to build a system to identify and trace certain prescription drugs as they are distributed in the United States. Ten years after enactment, the electronic, interoperable system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain.

Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices

This document provides guidance for the submission of the chemical and technological data that the Food and Drug Administration's Office of Food Additive Safety considers necessary for its evaluation of petitions requesting the listing of color additives for use in food, drugs, cosmetics, or medical

User Fee Lists

Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.

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