CDER

Why 2016 drug approvals fell
Why 2016 drug approvals fellWhile FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.
FDA approved more than 40 novel drugs in 2014FDA approved 41 new molecular entities in 2014, including several for cancer, type 2 diabetes, and hepatitis C.
Novel new drugs approved in 2014FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug applications (NDAs) and new therapeutic biologics submitted in biologics license applications (BLAs).
Will the pathway to approval of biosimilars run smoothly?As of July 24, Sandoz became the first to file for approval of a biologic under the biosimilar pathway. What will happen next remains to be seen.
Proposed new FDA rule might allow altered labeling of generic medsFDA's proposed new rule would allow individual generic-drug application holders to update product labeling information to temporarily reflect changes in safety information prior to FDA review.