Bumpus propelled to FDA’s second-in-command;Regulatory Affairs Professionals Society FDA二把手将退休:一个时代落幕;同写意 Namandjé Bumpus ’03;Occidental College Too many senior white academics still resist recognizing racism;Nature Protein pictures could yield thousands of drug targets;Nature Research ...
美国孤儿药资格认定及批准上市情况分析。 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer. 太平洋证券- 2023 年 FDA 批准新药数量接近记录,创新机制成主流 强生、礼来等公司官网、FDA等公开资料。
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug,...
首先,FDA收到NDA或BLA申请数量均呈现上升趋势;标准审评中位时间稳定在10个月左右,90%优先审评中位时间为6个月左右;1993财年产业提交的NDA或BLA首轮批准通过率仅为28%,到PDUFA Ⅰ末(1997财年)提升至44%,至巅峰时期标准审评首轮批准通过率为62%,优先审评首轮批准通过率为85%,据《Novel Drug Approvals for 2023...
求大神出来指点一下
gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-...
Upcoming: Drug Development Considerations for Empiric Antibacterial Therapy in Febrile Neutropenic Patients 美东时间2024年4月23日，FDA将举办一场题为“发热性中性粒细胞减少症（febrile neutropenia ，FN）患者经验性抗菌治疗的药物开发注意事项”的公开研讨会。该研讨会的目的是讨论临床试验设计以及与开发治疗FN的抗菌...
另外,为了特别关注复杂仿制药,FDA专门开辟了针对复杂仿制药PSG的新网页--即将发布的针对复杂仿制药的特定产品指南网页(Upcoming Product-Specific Guidances for Complex Generic Drug Product Development)(图1),每季度FDA发布PSG批次时,该网页会更新一次,每次更新都会删除已发布的PSG,并添加任何正在开发或修订中的新的...
4. Drug: Beremagene geperpavec Company: Krystal Biotech Indication(s): Dystrophic epidermolysis bullosa For the upcoming gene therapy candidates getting ready for BLA submission in the US, the first on the list is Krystal Biotech’s beremagene geperpavec, a topicalCOL7A1-expressing gene therapy ...
2013年 FDA 批准的新药 （Nature Review )