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- Drugs | FDA
FDA uses science and data to ensure that approved drugs are of a high quality, safe, and effective Learn more about the FDA’s role in reviewing, approving, and monitoring drugs in the latest
- Drug Approvals and Databases | FDA
Novel Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products Drug and Biologic Approval and IND Activity Reports This Week's Drug Approvals Drug Trials Snapshots
- Regulatory Information | FDA
Search for FDA guidance documents, learn about the laws enforced by FDA, and more
- Warning Letters | FDA
To obtain additional available information, contact FDA Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630
- FDA Newsroom | FDA
The latest news and events at the U S Food and Drug Administration (FDA) and resources for journalists
- Novel Drug Approvals for 2025 | FDA
To see the FDA-approved conditions of use [e g , indication (s), population (s), dosing regimen (s)] for each of these products, please see the most recently approved Prescribing Information (or
- Artificial Intelligence-Enabled Medical Devices | FDA
A direct link to the FDA’s database entry of an AI-enabled medical device is provided The database entry contains releasable information, such as summaries of safety and effectiveness
- Drug Safety and Availability | FDA
Advances in FDA's Drug Safety Programs (annual reports) Index to Drug-Specific Information FDA Drug Safety Podcasts FDA’s Labeling Resources for Human Prescription Drugs MedWatch Statement on
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