Disseminated Coccidioidomycosis: Developing Drugs for Treatment

Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review. The pilot program offers a new pathway for drug manufacturers to obtain FDA review of certain novel excipients (inactive ingredients)

Unapproved New Drugs/Misbranded

Discover FDA’s comprehensive list of registered outsourcing facilities engaged in human drug compounding. Get the latest updates, compliance guidelines, and resources to ensure safe, high-quality compounded medications. Explore regulations and stay informed with verified facility details.

Withdrawn and Expired Guidances | Drugs

Four FAERS summary statistics reports updated with data through December 31, 2013.