BioWorld9d
Uncertainty builds at US FDA with retirements, CR questions
The end of the year will be the end of an era at the FDA, as Bob Temple shuts his door at CDER for the last time Dec. 31.
腾讯网7d
2024年FDA新药盘点：小分子占据半壁江山，多肽和核酸类药物占比近10%
▎药明康德内容团队编辑截至12月19日，FDA旗下的药物评价和研究中心（CDER）已经批准了48款新药，而生物制品评价和研究中心（CBER）批准的基因疗法、细胞疗法、疫苗的数量达到10款。CDER批准新药中小分子药物占比约60%。近5年来，多肽和核酸 ...
JD Supra12d
FDA Announces New Center for Real-World Evidence Innovation
FDA’s Center for Drug Evaluation and Research (CDER) announced a new CDER Center for Real-World Evidence Innovation (CCRI).
FDA proposes pulling Sudafed and Benadryl from pharmacy shelves
Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in the agency's notice: 'It ...
Medscape5d
Role of FDA's Drug Information Centers
Further, many biologics are manufactured using biotechnology. CDER promotes and protects the public's health by ensuring that all prescription and nonprescription drugs marketed in the United ...
Indy 100 on MSN1mon
FDA issue order against common ingredient found in cold and flu medicine
"It is the FDA's role to ensure that drugs are safe and effective," Patrizia Cavazzoni, director of the administration's Center for Drug Evaluation and Research (CDER), said. "Based on our review ...
腾讯网13d
FDA 成立真实世界证据创新中心（CCRI）
美国 FDA 于 12 月 12 日宣布成立药品审评和研究中心（CDER）真实世界证据创新中心（CDER Center for Real-World Evidence Innovation，CCRI），以协调和促进真实世界数据（RWD）和真实世界证据（RWE）在监管决策中的使用。FDA ...