Learn about the OTC review process, drug monographs, and time and extent applications.
This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.
Learn about the uses, safety, and regulation of homeopathic medicines in the U.S.
Find frequently asked questions about OTC oral pain relievers and fever reducers including acetaminophen, aspirin, ibuprofen, ketoprofen, and naproxen sodium.
Advertising and marketing of dietary supplements are regulated by the FDA, the FTC, and other governmental organizations. Products must be deemed safe prior to marketing and advertisement claims must be substantiated.
The Annual Forecast for Planned Monograph Activities describes planned monograph activities that FDA intends to address over the ensuing three years.