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1. www.fda.gov › drugs › types-applicationsNew Drug Application (NDA) | FDA

   www.fda.gov › drugs › types-applications

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   The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the...

2. en.wikipedia.org › wiki › New_Drug_ApplicationNew Drug Application - Wikipedia

   en.wikipedia.org › wiki › New_Drug_Application

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   The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.

3. Vidéos

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     46:00

     youtube.com

     Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017

     6 août 2020

     18.3K vues

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     10:03

     youtube.com

     NEW DRUG APPLICATION | REGULATORY AFFAIR

     20 janv. 2022

     11.4K vues

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     1:0:47

     youtube.com

     Understanding New Drug Applications (NDAs)

     17 août 2018

     25.8K vues

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4. www.fda.gov › drugs › how-drugs-are-developed-andTypes of Applications | FDA - U.S. Food and Drug Administration

   www.fda.gov › drugs › how-drugs-are-developed-and

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   An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate...

5. www.nature.com › articles › s41587/024/02166-7Fresh from the biotech pipeline: record-breaking FDA ... - Nature

   www.nature.com › articles › s41587/024/02166-7

   26 févr. 2024 · Nature Biotechnology - New drug approvals reached an all-time high in 2023, with five gene therapies, the first CRISPR–Cas9-edited therapy and a disease-modifying Alzheimer’s drug.

   • Auteur: Melanie Senior

6. www.ecfr.gov › current › title-21eCFR :: 21 CFR Part 314 -- Applications for FDA Approval to ...

   www.ecfr.gov › current › title-21

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   Application, new drug application, or NDA is the application described under § 314.50, including all amendments and supplements to the application. An NDA refers to “stand-alone” applications submitted under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act and to 505(b)(2) applications.

7. www.drugs.com › fda-approval-processFDA Drug Approval Process - Drugs.com

   www.drugs.com › fda-approval-process

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   28 mai 2022 · Learn how the FDA reviews and approves new drugs in the U.S. before they are marketed. The web page explains the four phases of clinical trials, the New Drug Application (NDA), and the post-marketing risk assessments.

8. www.nature.com › articles › s41392/024/01770-yTargeted drug approvals in 2023: breakthroughs by the FDA and ...

   www.nature.com › articles › s41392/024/01770-y

   20 févr. 2024 · Notably, domestic innovation is flourishing, with five first-in-class drugs, including Glumetinib, a c-Met inhibitor from Haihe Biopharma; Leritrelvir, a 3CL protease inhibitor from Raynovent;...