A new report in RAPS sheds light on the increase in BLAs coupled with a rise in CRLs issued by the CDER. CDER Director Patrizia Cavazzoni presented this information at a meeting on biologics and bios…
4 Best Practices for Preventing CRLs in Biologics Manufacturing
Coinciding with more BLAs in recent years, CDER is handing out more CRLs related to manufacturing issues. Here are a few ways to prevent one yourself.
