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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 > -
Document: Minutes of the PRAC meeting 5-8 May 2025-2025/7/4
2025-07-07查看详情 > -
Document: Vaccine Monitoring Platform: List of EMA-funded studies-2025/8/7
2025-08-10查看详情 > -
Page: List of medicines under additional monitoring-2025/9/24
2025-09-25查看详情 > -
Document: Policy 46: European Medicines Agency policy on video surveillance-2025/11/3
2025-11-04查看详情 >