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Document: Bioabsorbable orthopaedic screws - Notified body 0344 - 14/05/2024 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)-2026/3/24
2026-03-25查看详情 > -
Page: Website outages and upgrades-2026/4/29
2026-04-30查看详情 > -
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals (Final)-2022/10/3
2022-11-14查看详情 > -
国家药监局药审中心关于发布《基于动物法则的药物研究技术指导原则（试行）》的通告（2023年第26号）-2023/4/7
2023-04-10查看详情 > -
关于公开征求《化学仿制药生物等效性研究摘要（征求意见稿）》意见的通知-2023/10/07
2023-10-08查看详情 > -
Document: EudraVigilance human - Sponsor registration form-2025/1/7
2025-01-08查看详情 > -
Page: Overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - Scientific guideline-2025/2/13
2025-02-14查看详情 > -
Page: Paediatric investigation plans: questions and answers-2025/3/24
2025-03-25查看详情 > -
Document: FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation (archive)-2025/4/24
2025-04-27查看详情 > -
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver Draft -2025/5/30
2025-06-06查看详情 >
