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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
Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the
- 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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