- U. S. Food and Drug Administration
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the
- Regulatory Information | FDA
Search for FDA guidance documents, learn about the laws enforced by FDA, and more
- 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
- Registration and Listing | FDA
Domestic and foreign establishments that manufacture, repack, or re-label drug and biologic products, including vaccines, are required to register with the FDA
- Medical Device Databases | FDA
CDRH Databases: a listing of databases for such topics as advisory committees, regulations, good practices, medical devices, Premarket Approval (PMA) and Notification (510 (k)), product codes
- Roadmap to Reducing Animal Testing in Preclinical Safety Studies
This scientific roadmap lays out an initial strategy for FDA to reduce and replace animal testing in preclinical safety assessment of drugs and biologics and will be refined based on feedback
- FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease
The FDA, an agency within the U S Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines
- 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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