The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory ...

美国 FDA 于 11 月 21 日发布了一批 400 多个含有非甾体抗炎药（non-steroidal anti-inflammatory drugs，NSAID）的药品的补充标签批准，从阿司匹林、布洛芬到双氯芬酸钾。在药品审评与研究中心（CDER）同一天更新的药品安全性相关标签变更（Drug Safety-related Labeling Changes，SrLC）库中，可查到这些药品批准的补 ...

看点1. 美国FDA批准5款创新药上市2. NMPA批准3款创新药上市3. 113个新药在国内获得临床试验默示许可图1.

“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve ...

Drug Discov. 7, 107–109; 2008) — the FDA has been actively recruiting new employees, and CDER achieved a net gain of 396 staff in FY 2008 with 121 specifically working in the OND.

MATTB provides assistance and training through outreach to industry. A: CDER's Division of Drug Information (DDI) serves as a focal point for public inquiries regarding human drug products.

During his December 2009 presentation to the FDA–CMS (Centers for Medicare and Medicaid Services) summit, John Jenkins, Director of the Office of New Drugs at CDER, noted that “Incorporating ...

director of the administration's Center for Drug Evaluation and Research (CDER), said. "Based on our review of available data, and consistent with the advice of the advisory committee, we are ...

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.

Report on Research Compliance 17, no. 5 (May 2020) - Study sponsors should be making additional efforts to enroll older individuals in cancer trials, incorporating such strategies in study design ...

Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research (CDER), emphasized that the agency's role is to ensure drugs are both safe and effective. She noted that ...