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行政資料
- 事務連絡「「トキシコキネティクス（毒性試験における全身的暴露の評価）に関するガイダンス」におけるマイクロサンプリング手法の利用に関する質疑応答集（Ｑ＆Ａ）について」 2019/03/15
- EMA ”Draft ICH guideline M10 on bioanalytical method validation - Step 2b” 2019/03/14
- FDA "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act" Guidance for Industry 2019/03/01
- FDA "Quality Considerations for Continuous Manufacturing Guidance for Industry" DRAFT GUIDANCE 2019/02/26
- FDA "Bioavailability Studies Submitted in NDAs or INDs — General Considerations" Guidance for Industry 2019/02/25
- FDA "Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations" Guidance for Industry 2019/02/25
- Overview of comments received on ICH guideline M9 on biopharmaceutics classification system based biowavers 2019/02/22
- Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2019 2019/02/20
- FDA "CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality" 2019/02/13
- 薬生機審発0201第1号「医療機器及び体外診断用医薬品の承認申請等に関する質疑応答集（Q&A）について（その2）」 2019/02/01