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1. www.fda.gov › medical-devicesMedical Devices | FDA - U.S. Food and Drug Administration

   www.fda.gov › medical-devices

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   2024 Regulatory Education for Industry (REdI) Conference. On May 29-30, 2024, hear from FDA’s regulatory experts in medical product centers: devices, drugs, and biologics. The conference is free ...

2. www.fda.gov › regulatory-information › search-fda-guidanceElectronic Submission Template for Medical Device 510(k) ...

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

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   2022年9月22日 · FDA is identifying October 1, 2023 as the date on which we will require that 510 (k) electronic submissions be provided. FDA intends to accept 510 (k) submissions saved to a form of electronic ...

3. www.fda.gov › regulatory-information › search-fda-guidanceQ1A(R2) Stability Testing of New Drug Substances and ...

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

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   Center for Biologics Evaluation and Research. This guidance is the second revision of Q1A Stability Testing of New Drug Substances and Products, which was first published in September 1994 and...

4. www.fda.gov › regulatory-information › search-fda-guidanceData Integrity and Compliance With Drug CGMP: Questions and ...

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

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   The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Data Integrity and Compliance With Drug CGMP: Questions and Answers ...

5. www.fda.gov › regulatory-information › search-fda-guidanceANDAs: Stability Testing of Drug Substances and Products, ...

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

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   2020年4月22日 · Guidance Issuing Office. Center for Drug Evaluation and Research. This guidance provides answers to questions from the public comments we received on the draft guidance for industry on ANDAs:...

6. www.fda.gov › drugs › forms-submission-requirementsElectronic Regulatory Submission and Review | FDA

   www.fda.gov › drugs › forms-submission-requirements

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   2022年1月18日 · Select “CDER” as the Center . Select “ECTD” as Submission Type . Use any 6-digit number as the test application number . Select an eCTD sequence folder. Do not submit a single file as this ...

7. www.fda.gov › drugs › types-applicationsInvestigational New Drug (IND) Application | FDA

   www.fda.gov › drugs › types-applications

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   10/1/2000. Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB ...