For specific application or supplement questions, please contact
- Office of New Drugs prescription drug review division for NDAs/BLAs regulated in Center for Drug Evaluation and Research (CDER)
- Office of Generic Drugs for ANDAs regulated in CDER
- Center for Biologics Evaluation and Research (CBER) for ANDAs, BLAs, or NDAs regulated in CBER
For general questions about the Prescribing Information or this website contact the Labeling Policy Team in CDER.
*For the purposes of these webpages, references to drugs include drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act and biological products licensed under section 351 of the Public Health Service Act that are regulated as drugs. Not every resource on this website will be applicable to every prescription drug.