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- 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
- 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
- Food and Drug Administration | FDA
On Oct 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency We are in the process of updating FDA gov content to reflect these changes
- 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
- 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
- Inspection Classification Database | FDA
The Food and Drug Administration (FDA) inspects and assesses regulated facilities to determine a firm's compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act
- Commissioners National Priority Voucher (CNPV) Pilot Program | FDA
The CNPV pilot program reflects the FDA's broader commitment to create more efficient approval processes and modernize regulatory frameworks for greater agility to meet emerging public health needs
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