美国食品药品监督管理局(FDA)药品评价研究中心(CDER)共批准了21种新药，包括17个化药和6个生物药，批准数量比2023年同期略低，但仍处于历史平均 ...

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.

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 ...

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.

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

while she was the director of the Center for Drug Evaluation and Research (CDER). The FDA, at the behest of Woodcock, overruled significant internal dissension to approve Exondys, a therapy for ...

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post. FDA’s Patrizia Cavazzoni, director, Center for Drug ...

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 ...