腾讯网

FDA 探索模型主文件（MMF）以加快仿制药开发

美国 FDA 正在探索模型主文件（Model Master File，MMF），以便申办人能够使用相同的建模方法代替临床研究来支持可能来自不同申办人的仿制药开发项目。FDA 和复杂仿制药研究中心（CRCG）于 5 月 2 到 3 日联合主办了 MMF 的注意事项和潜在监管应用的研讨会。 FDA 官员 ...
Business Wire

Trial Master File Reference Model Group Officially Affiliates with CDISC

AUSTIN, Texas--(BUSINESS WIRE)--CDISC today announced an expansion of its offerings with the official affiliation of volunteer-based Trial Master File (TMF) Reference Model Group. The combined ...
Pharmabiz

Stellar submits Biological Master File to US FDA for subunit KLH

Stellar Biotechnologies, Inc., the world leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), has submitted a Type IV Biologics Master File (BB-MF) to the US Food and Drug ...