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Scientific guideline: Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance-2022/12/16
2022-12-19查看详情 > -
Draft Guidance: Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act-2023/6/27
2023-06-28查看详情 > -
Final Guidance: Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products-2023/12/21
2024-01-03查看详情 > -
Document: Policy 83: Policy on visiting and collaborating experts involved in the activities of the European Medicines Agency-2025/1/23
2025-01-24查看详情 > -
国家药监局关于发布《血液净化体外循环系统 血液透析器、血液透析滤过器、血液滤过器及血液浓缩器用体外循环血路/液路》等10项医疗器械行业标准的公告（2025年第21号）-2025/2/28
2025-03-03查看详情 > -
Document: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes-2025/4/4
2025-04-07查看详情 > -
国家药监局关于修订盐酸雷尼替丁注射制剂说明书的公告（2025年第49号）-2025/5/16
2025-05-16查看详情 > -
Document: Article 57 product data-2025/6/24
2025-06-25查看详情 > -
Page: COVID-19 vaccines: key facts-2025/7/28
2025-07-29查看详情 > -
国家药监局药审中心关于发布《创新药研发期间风险管理计划撰写技术指导原则（试行）》的通告（2025年第38号）-2025/9/12
2025-09-12查看详情 >
