LONG BEACH, CA – The number of complete response letters (CRLs) issued to sponsors of biologics license applications (BLAs) by the US Food and Drug Administration (FDA) has been increasing over the ...
The US Food and Drug Administration (FDA) has finalized guidance specifying that after 1 April 2026, sponsors will have to submit investigational new drug (IND) safety reports for serious and ...
Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Compliance & Enforcement Team examines a new FDA compliance program for Center for Drug Evaluation and Research (CDER)-regulated biologics, highlighting the ...
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