On December 30th, 2022, President Biden signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), which included an Act now signed into law entitled the Modernization of Cosmetic Regulations Act of 2022...more
On May 26, Senators Murray and Burr introduced S. 4348 (pg. 97). The primary focus of the bill was to pass reauthorizations of FDA’s critical user fee programs for drugs, medical devices and biologics, which are scheduled to...more
As is typical with the FDA, the Agency chose the end of the year to publish the fees it intended to collect from over-the-counter (OTC) monograph drug manufacturers under the OTC Monograph User Fee Act (OMUFA). In its...more
Buried at page 415 of the Coronavirus Relief Bill is an Amendment to the Federal Food Drug and Cosmetic Act which Completely Changes How Over the Counter Drugs are Regulated by the FDA
With few exceptions for drugs like...more
On February 26, 2019, the FDA published yet another additional proposed rule in the proceedings to finalize the OTC Sunscreen Monograph.
Comments on the proposed rule may be filed with the FDA within 90 days from the...more