资讯

FDA Chief Says He Wants Gene Therapy Head Prasad to Return
US Food and Drug Administration Commissioner Marty Makary said he’s trying to persuade Vinay Prasad, the agency’s former head ...
腾讯网6 天
FDA CBER主任，首席医学和科学官Prasad突然离职
7月29日，美卫生部发言人宣布FDA生物制品评价与研究中心（CBER）主任Vinay Prasad离职，距离其上任不过百日。上一任CBER主任Peter Marks于3月28日被迫离职。
Vinay Prasad, High-Risk Drugs and the FDA
U.S. Food and Drug Administration officials should encourage the thoughtful and careful evaluation of drugs.
被“清算”的FDA主任，与CGT的未来
随着FDA资深人士大批离开后，新药评审所需的专业能力是在减弱而非得到加强。因此，行业的观察是，FDA对IND、BLA以及NDA的审批速度将大大减慢，许多产品和公司可能要“面临漫长而昂贵的停滞期，迟迟得不到任何进展”。
Why Vinay Prasad Had to Go at FDA
The gene therapy chief wanted to block fast-track drug approvals.
FDA改朝，临床监管变严了？
目前来看，市场的担忧并非空穴来风。Replimune的遭遇更是给所有创新药企敲响了警钟，在FDA领导层更迭的背景下，监管标准的连贯性正在断裂，曾经达成共识的临床设计，也可能在新主任上任后面临颠覆性质疑。
STAT8 天
Vinay Prasad, a powerful FDA official, departs after controversy over rare disease drug
Vinay Prasad, a top official at the Food and Drug Administration, has suddenly departed after a series of controversial ...
Controversial vaccine official Dr. Vinay Prasad departs FDA
Dr. Vinay Prasad had been serving as the FDA's director of the Center for Biologics Evaluation and Research since May, and ...
US FDA's top vaccine official Vinay Prasad leaves agency after 3 months
The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as ...
FDA改朝，溶瘤病毒遭殃？
目前来看，市场的担忧并非空穴来风。Replimune的遭遇更是给所有创新药企敲响了警钟，在FDA领导层更迭的背景下，监管标准的连贯性正在断裂，曾经达成共识的临床设计，也可能在新主任上任后面临颠覆性质疑。
Fierce Pharma6 天
Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell ...
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
Townhall5 小时Opinion
What the Hell Is Happening Over at the FDA?
One great example of a “what the hell is happening here” story run just the other day that opened with, “Orange juice, known ...