Submit Comments by 09/29/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Below are frequently asked questions and the associated answers sorted by topic area.  Drug Review What information and types of notifications are provided to sponsors during […]

By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research CDER Director, Patrizia […]

FDA Opens Doors for More Treatments for Rare Diseases through the New START Pilot Program By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research […]

Image By: Robert M. Califf, MD, Commissioner of Food and Drugs During my career as an academic researcher, physician, and public health official, I’ve tried to […]

State-licensed physicians and pharmacists that compound under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may only compound drug products using bulk […]

AOD-9604 503A September 29, 2023 Compounded drugs containing AOD-9604  may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard […]

August 4, 2017 Summary Two patients administered infusions of curcumin (a component of the spice turmeric) compounded with polyethylene glycol (PEG) 40 castor oil reportedly experienced […]

The Compounding Quality Act requires the Secretary to establish a mechanism to receive submissions from state boards of pharmacy concerning certain actions taken against compounding pharmacies […]