Development & Approval Process | Drugs | FDA - U.S. Food and …
Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.
The Drug Development Process | FDA
FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it. More Information Step 5
Frequently Asked Questions about the FDA Drug Approval Process
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.
The FDA's Drug Review Process: Ensuring Drugs Are Safe and …
Video Series - Overview of Our Role Regulating and Approving Drugs; How Drugs are Developed and Approved; Frequently Asked Questions about the FDA Drug Approval Process; Resources
How Drugs are Developed and Approved | FDA - U.S. Food and …
Oct 24, 2022 · 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 test it and submit ...
Learn About Drug and Device Approvals | FDA - U.S. Food and …
FDA is speeding up the approval process for Drugs and Medical Devices. Learn how medical products are approved.
Drug Approvals and Databases | FDA
Drug Approvals and Databases | FDA
FDA's Drug Review Process: Continued | FDA - U.S. Food and Drug ...
PDUFA has allowed the Food and Drug Administration to bring access to new drugs as fast or faster than anywhere in the world, while maintaining the same thorough review process.
The Generic Drug Approval Process | FDA
What is the Approval Process for Generic Drugs? CDER Conversations: Generic Drugs in the 21st Century: FDA’s Actions Create Transparency and Value for Complex Generic Product Development Resources
FDA Drug Approval Process Infographic (Vertical)
High-Resolution, printable PDF of the Drug Approval Process Infographic - PDF [3.9 MB] Developed by FDA's Center for Drug Evaluation and Research