Monograph reform is here! Learn what to expect and how to prepare.

CDER’s Office of Nonprescription Drugs Director Theresa M. Michele, MD, and Deputy Director Karen M. Mahoney, MD, discuss the key elements of the Monograph Reform legislation including Monograph Order Requests and Administrative Orders. They also share how FDA will transition all the monographs into Administrative Orders and how sponsors who have over-the-counter drugs might consider preparing for monograph reform.


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