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
FDA recently issued its new final guidance concerning the appropriate pathway for review of drug-device combination products, Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff. In...more
The FDA has taken action to accelerate the approval of Abbreviated New Drug Applications (“ANDAs”). With a goal of reducing the number of review cycles needed to reach approval, the FDA will save generic drug companies money...more