Tag: biological license application

biological license application

Regulatory/FDA

CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges

CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges

Jan. 4, 2022 – 2021 was a year of many healthcare challenges, but against this backdrop the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 50 novel drugs and its Center for Biologics Evaluation and Research (CBER) approved 10 biological license applications (BLAs) (plus three source plasma products). CDER nearly […]

Read more