约 3,280,000 个结果
在新选项卡中打开链接
  1. fda.gov
    https://www.fda.gov/regulatory-information/search-fda-guidance...

    M11 Template: Clinical Electronic Structured Harmonised Protocol - FDA

  2. fda.gov
    https://www.fda.gov/medical-devices/how-study-and-market-your...

    eSTAR Program | FDA - U.S. Food and Drug Administration

  3. fda.gov
    https://www.fda.gov/drugs/drug-master-files-dmfs/drug-master-file...

    Drug Master File (DMF) Templates | FDA

  4. fdanews.com
    https://www.fdanews.com/ext/resources/files/2017/05/05-02-17-FDANI...
    [PDF]

    NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol

  5. zhihu.com
    https://zhuanlan.zhihu.com/p/405289346

    FDA免费模板库 eSTAR：510 (k)递交新方式 - 知乎 - 知乎专栏

  6. zhihu.com
    https://zhuanlan.zhihu.com/p/650559506

    FDA 510k新的递交方式eSTAR - 知乎 - 知乎专栏

  7. medsci.cn
    https://www.medsci.cn/guideline/show_article.do?id=...

    2024 FDA指南：医疗器械从头申请的电子提交模板

  8. emergobyul.cn
    https://www.emergobyul.cn/zh-hans/resources/mei-guo-fda-estardian...

    美国FDA eSTAR电子递交模板与资源要求解析 - Emergo

  9. zhihu.com
    https://zhuanlan.zhihu.com/p/574622524

    2022年FDA发布了医疗器械 510(k) 电子提交模板 - 知乎

  10. gcpunion.org
    http://www.gcpunion.org/web/static/articles/catalog_ff8080815702574c...
    [PDF]

    NIH-FDA IND/IDE II 期、III期临床试验