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 ...
Nasdaq

FDA Accepts Tasly's Device Master File, Setting First Quality Control Standard For MSCs

(RTTNews) - Tasly announced that, in a landmark move for the cell therapy industry, the U.S. Food and Drug Administration has accepted a Device Master File (DMF) describing the first dedicated quality ...
RAPS

FDA exploring model master files to expedite generic drug development

The US Food and Drug Administration (FDA) is exploring the use of model master files (MMFs) to enable sponsors to use the same modeling approach to support different generic drug development programs, ...
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 ...
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 ...