US Food and Drug Administration Commissioner Marty Makary said he’s trying to persuade Vinay Prasad, the agency’s former head ...

近期，美国食品药品监督管理局（ FDA ）前生物制品评估与研究中心（ CBER ）主任 Vinay Prasad 的离职事件持续发酵， FDA 局长 Marty Makary 公开表示希望 Prasad 重返岗位，引发多方关注与争议。

The gene therapy chief wanted to block fast-track drug approvals.

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。

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”。

Vinay Prasad, a top official at the Food and Drug Administration, has suddenly departed after a series of controversial ...

The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as ...

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。

U.S. Food and Drug Administration officials should encourage the thoughtful and careful evaluation of drugs.

Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

Vinay Prasad recently drew outrage from conservatives, including Laura Loomer, who disagreed with his approach to approving ...