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Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection-2026/3/6
2026-03-09查看详情 > -
Document: European Medicines Agency's data protection notice for the implementation of the Instrument for Pre-accession Assistance (IPA) programme-2026/4/7
2026-04-08查看详情 > -
Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)-2022/12/16
2022-12-19查看详情 > -
Final Guidance: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements-2023/6/27
2023-06-28查看详情 > -
Final Guidance: Rare Diseases: Considerations for the Development of Drugs and Biological Products-2023/12/22
2024-01-03查看详情 > -
Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)-2025/1/31
2025-02-05查看详情 > -
Document: Clinical Trial Information System (CTIS) evaluation timelines-2025/2/27
2025-03-03查看详情 > -
Document: SMS guidance for external users-2025/4/4
2025-04-07查看详情 > -
图解海报 |《化妆品安全风险监测与评价管理办法》系列解读（四）-2025/5/16
2025-05-16查看详情 > -
Page: Plasma master file certificates-2025/6/24
2025-06-25查看详情 >
