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Approvals of FDA-Regulated Products | FDA
https://www.fda.gov/news-events/approvals-fda-regulated-products
WEBApproval information by product type Drugs. Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes) Drug Approval Reports...
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Drug Approvals and Databases | FDA
https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases
WEBNew Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. This Week's Drug Approvals. CDER highlights key Web sites. Web page provides quick links to everything...
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FDA Approves First COVID-19 Vaccine | FDA - U.S. Food and Drug
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
WEBAug 23, 2021 · 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...
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Development & Approval Process | Drugs | FDA
https://www.fda.gov/drugs/development-approval-process-drugs
WEBGet to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.
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Why Pfizer's FDA Approval Matters And What It Means For …
https://www.npr.org/sections/coronavirus-live-updates/2021/08/24/1030267314/pfizer-vaccine-covid-fda-approval-kids-faq-mandate
WEBAug 24, 2021 · The FDA announced the Pfizer vaccine is the first in the U.S. that is now fully approved. Here's what that means for vaccine mandates and convincing vaccine-hesitant people to get vaccinated.
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About FDA Product Approval | FDA - U.S. Food and Drug …
https://www.fda.gov/news-events/approvals-fda-regulated-products/about-fda-product-approval
WEBAbout FDA Product Approval. The Food and Drug Administration's regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. These...
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Novel Drug Approvals for 2024 | FDA
https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024
WEBDrug Name. Active Ingredient. Approval Date. FDA-approved use on approval date*. 11. Zevtera. ceftobiprole medocaril sodium. 4/3/2024. To treat certain bloodstream infections, bacterial skin and ...
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Learn About Drug and Device Approvals | FDA
https://www.fda.gov/patients/learn-about-drug-and-device-approvals
WEBFDA is speeding up the approval process for Drugs and Medical Devices. Learn how medical products are approved.
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Frequently Asked Questions about the FDA Drug Approval Process
https://www.fda.gov/drugs/special-features/frequently-asked-questions-about-fda-drug-approval-process
WEBThis article discusses why drugs are evaluated by FDA, the different types of drug applications, and the length of time it takes for a drug to be approved.
DA: 96 PA: 76 MOZ Rank: 23
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FDA Approves Pfizer Vaccine: Live Updates - The New York Times
https://www.nytimes.com/live/2021/08/23/world/covid-delta-variant-vaccine
WEBAug 23, 2021 · The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, making it the first to move beyond emergency-use status in the ...
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