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2. Drug Approvals and Databases | FDA - U.S. Food and Drug...

   www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases

   Additional topics include: approved REMS, drug shortages, and the Orange book. CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and ...

3. COVID-19 Vaccines | FDA - U.S. Food and Drug Administration

   www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid...

   The FDA approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in ...

4. FDA Approves First COVID-19 Vaccine

   www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

   FDA approved the first COVID-19 vaccine, which has been known as the Pfizer-BioNTech COVID-19 Vaccine, and is now marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease ...

5. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to...

   www.fda.gov/news-events/press-announcements/fda-approves-and-authorizes...

   FDA approved and authorized for emergency use updated mRNA COVID-19 vaccines (2024-2025 formula) to more closely target currently circulating variants to prevent COVID-19 and to provide better ...

6. U.S. Food and Drug Administration

   www.fda.gov

   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 ...

7. Is It Really 'FDA Approved'? - U.S. Food and Drug Administration

   www.fda.gov/consumers/consumer-updates/it-really-fda-approved

   The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and ...

8. Development & Approval Process | Drugs | FDA

   www.fda.gov/drugs/development-approval-process-drugs

   Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.

9. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss

   www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/...

   Many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products. As of August 31, 2024, FDA has received:

10. Approvals of FDA-Regulated Products

    www.fda.gov/news-events/approvals-fda-regulated-products

    Recently-Approved Devices; Animal Drugs. Animal Drugs @ FDA; Animal Drug User Fee Act (ADUFA) Animal Generic Drug User Fee Act (AGDUFA) Food Additives. Food and Color Additives: Final Rules by Year;

11. Resources for Information | Approved Drugs | FDA

    www.fda.gov/drugs/drug-approvals-and-databases/resources-information-approved...

    Drugs@FDA does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (vaccines, allergenic products, blood and blood products, plasma ...