The head of the US Food and Drug Administration department responsible for assuring the safety and effectiveness of vaccines ...
近日,太美医疗科技药物警戒团队助力乘典生物完成FDA Gateway联调测试。此次联调测试的目标在于满足FDA最新监管要求,加强公司药物警戒国际化运营能力。 2024年4月1日,美国FDA发布了关于电子提交新药临床研究申请(IND)安全报告的最终指南。指南规定: 2026 年 4 月 1 日之后,IND申请必须向 FDA 的不良事件报告系统(FAERS)提交满足E2B ...
Marks was pushed out under pressure from HHS Secretary Robert F. Kennedy Jr., said two people familiar with the matter granted anonymity to discuss the resignation — a development that sent shockwaves ...
Jiangsu Hengrui Pharmaceuticals and its partner Elevar Therapeutics will have to wait even longer before their PD-1 inhibitor ...
A top vaccine advisor at the FDA was forced to resign on Friday. In his resignation letter, Dr. Peter Marks wrote "truth and transparency are not desired," by HHS Secretary Robert F. Kennedy Jr.
In his resignation letter, Marks rebuked Kennedy for seeking “subservient confirmation of his misinformation and lies” about vaccines.