FDA-TRACK Update: Track all upcoming FDA rules and regulations through Unified Agenda-TRACK


On Track: The FDA-TRACK Monthly Newsletter

FDA Track

Learn More: Unified Agenda

As required by law, FDA publishes regulations in the Federal Register, the U.S. Government's official publication for notifying the public of many kinds of agency actions.  Regulations are either required or authorized by statute.  Some address a specific problem or known health hazard like FDA's egg safety regulations, while others are administrative or procedural like FDA's new drug application regulations.  Because of their importance, an agency's rulemaking plans are of great interest to a wide range of stakeholders. 

The Federal Government publishes a semi-annual agenda of upcoming regulations.  This is published in the Federal Register twice a year, usually in the Spring and Fall.  As part of FDA's Transparency Initiative and FDA-TRACK, FDA's Office of Policy and Planning also provides updates on FDA's upcoming rulemakings on a web page titled, "Unified Agenda–TRACK."  On this web page, FDA will maintain an updated agenda of the FDA rulemakings that are listed in the Unified Agenda.  The purpose is to better inform the public about the status of FDA's important rulemakings and to promote the transparency of regulatory processes.


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