FDA Answers Questions on NDA-BLA Transition as March 23 Approaches
The FDA released final guidance on the transition of insulin and other biological products from new drug applications (NDAs) to biologics license applications (BLAs) as the March 23 transition date looms.
In general, sponsors of biological products that were assessed PDUFA fees prior to the transition will continue to be assessed such fees after March 23, the agency said.
In addition, approved NDAs transitioned to BLAs will generally remain under the same review office/division in CDER’s Office of New Drugs.
FDA Commissioner Stephen Hahn said the transition will open “new pathways for manufacturers to bring products to market,” increasing competition and potentially lowering costs.