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 …
FDA en español | FDA
La FDA es responsable de proteger la salud pública asegurando la seguridad, eficacia y protección de los medicamentos, los productos biológicos y los dispositivos médicos humanos …
Recalls, Market Withdrawals, & Safety Alerts | FDA
Recalls, Market Withdrawals, & Safety Alerts The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products.
Drug Approvals and Databases | FDA
Sep 24, 2025 · 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 …
U S Food and Drug Administration Home Page
April 12, 2019 - FDA approves first targeted therapy for metastatic bladder cancer
FDA Newsroom | FDA
Oct 2, 2024 · The latest news and events at the U.S. Food and Drug Administration (FDA) and resources for journalists.
Novel Drug Approvals for 2025 | FDA
Oct 24, 2025 · 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 …
Artificial Intelligence-Enabled Medical Devices | FDA
Oct 7, 2025 · The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate artificial intelligence (AI).
Orange Book: Approved Drug Products with Therapeutic …
Please send general questions related to the drug data in these files to the Center for Drug Evaluation and Research, Division of Drug Information: [email protected].
FDA Dashboards - Inspections
FDA does not issue CGMP certificates at the conclusion of an inspection. Instead, this dashboard provides the outcomes, including classification and other details, of a firm’s most recent …