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。

周一美股盘前，多家生物科技公司股价出现下跌。此前有报道称，曾被解职的美国食品药品监督管理局 (FDA)疫苗监管官员Vinay Prasad将重返该机构。 截至发稿，Capricor Therapeutics (CAPR.US)下跌近8%，Sarepta Therapeutics (SRPT.US)下挫超4%，Replimune (REPL.US)跌幅近7%。

*图片来自网络，仅作示意用当地时间8月9日，美国卫生部（HHS）发言人向美媒确认，Vinay Prasad医学博士在7月29日离职约10天后回归FDA，仍然担任生物制品审评与研究中心（Center for Biologics Evaluation ...

Vinay Prasad, the U.S. Food and Drug Administration's top vaccine regulator, is returning to his post less than two weeks ...

CBER（FDA 生物制品评估与研究中心）主任Vinay Prasad被市场称为史上最戏剧的人事波动，他最初于被FDA局长Marty Makary任命于5月6日首次上任，随后7月29日以“不想成为 FDA ...

Vinay Prasad, who was ousted as the top vaccine and gene therapy regulator at the US Food and Drug Administration, is ...

Vinay Prasad, M.D., has rejoined the FDA, the latest turn in a monthslong stretch of leadership turnover at the agency. | “At ...

Dr. Vinay Prasad had been serving as the FDA's director of the Center for Biologics Evaluation and Research since May, and ...

A Food and Drug Administration official who stepped down less than two weeks ago is getting his job back as the agency’s top ...

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...

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’s three-month tenure as one of the top officials at the Food and Drug Administration was bad for medicine. But his forced departure is probably worse. It will likely be celebrated ...