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Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP-2026/3/19
2026-03-20查看详情 > -
Page: Referentials Management Service (RMS)-20256/4/23
2026-04-24查看详情 > -
国家药监局关于启用生物制品批签发电子证明、麻醉药品和精神药品实验研究立项电子批件的公告（2022年第84号）-2022/10/11
2022-11-14查看详情 > -
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens(Draft)-2023/03/01
2023-03-01查看详情 > -
Final Guidance: Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products-2023/9/8
2023-09-14查看详情 > -
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act-2025/1/7
2025-01-07查看详情 > -
Document: Guide to manufacturers on the procedure for requesting advice from expert panels on clinical investigations and / or clinical development strategies for high-risk medical devices-2025/2/10
2025-02-11查看详情 > -
Document: List of signals discussed at PRAC since September 2012-2025/3/17
2025-03-18查看详情 > -
国家药监局关于注销安喘片等5个品种药品注册证书的公告（2025年第39号）-2025/4/17
2025-04-18查看详情 > -
Document: List of signals discussed at PRAC since September 2012-2025/6/2
2025-06-03查看详情 >
