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1. www.fda.govU S Food and Drug Administration Home Page

   www.fda.gov

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   U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

2. www.fda.gov › about-fda › center-drug-evaluation-and-researchCDER Center for Clinical Trial Innovation (C3TI) | FDA

   www.fda.gov › about-fda › center-drug-evaluation-and-research

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   Linkedin. The Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI) is a central hub that supports innovative approaches to clinical trials that are designed ...

3. www.fda.gov › about-fda › cder-center-clinical-trialAbout CDER Center for Clinical Trial Innovation (C3TI) | FDA

   www.fda.gov › about-fda › cder-center-clinical-trial

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   2024年4月15日 · Linkedin. CDER established the CDER Center for Clinical Trial Innovation (C3TI) in April 2024 to enable and amplify innovative approaches to clinical trials that are designed to improve the ...

4. www.fda.gov › regulatory-information › search-fda-guidanceManufacturing Considerations for CGT Products During COVID

   www.fda.gov › regulatory-information › search-fda-guidance

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   2021年1月19日 · You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and ...

5. www.fda.gov › regulatory-information › search-fda-guidanceConsiderations for the Use of Human-and Animal-Derived ...

   www.fda.gov › regulatory-information › search-fda-guidance

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   2024年4月29日 · The use of human- and animal-derived materials to manufacture cellular and gene therapy (CGT) products and tissue-engineered medical products (TEMPs) raises several key issues to consider ...

6. www.fda.gov › drugs › news-events-human-drugsRegulatory Education for Industry (REdI) Annual Conference ...

   www.fda.gov › drugs › news-events-human-drugs

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   2024年4月8日 · PLENARY Innovation of medical products, whether it be drugs, devices, or biologics, is a continual journey that advances the needs of patients today and of future generations. Innovation takes the ...

7. www.fda.gov › medical-devices › recently-approved-devicesResolute Onyx Zotarolimus-Eluting Coronary Stent System, ...

   www.fda.gov › medical-devices › recently-approved-devices

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   2023年3月10日 · What is it? The Resolute Onyx Zotarolimus-Eluting Coronary Stent System (Resolute Onyx) and Onyx Frontier Zotarolimus-Eluting Coronary Stent System (Onyx Frontier) are intended to treat a narrowed...