Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

New Drug Application (NDA)--This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States.

This article discusses why drugs are evaluated by FDA, the different types of drug applications, and the length of time it takes for a drug to be approved.

High-Resolution, printable PDF of the Drug Approval Process Infographic - PDF [2.8 MB] Developed by FDA's Center for Drug Evaluation and Research Related Information

2022年10月24日 · Some companies submit a new drug application (NDA) to introduce a new drug product into the U.S. Market. It is the responsibility of the company seeking to market a drug to …

Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval. After an NDA is received, the FDA has 60 days to decide whether to file it so it can …

FDA is speeding up the approval process for Drugs and Medical Devices. Learn how medical products are approved.

Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals; Novel Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Find out how the FDA is Speeding Up the Approval Process. New Drug Application. A New Drug Application (NDA) tells the full story of a drug.