Drug Approval Process
FDA’s Pazdur Raises Concerns Over Legality of National Priority Voucher Program Amid Internal Disagreement
FDA; Pazdur; Commissioner’s National Priority Voucher; CNPV; legality; internal disagreement; tumor board; Tidmarsh; drug approval process
Xspray’s Dasynoc Faces FDA Approval Delay Due to Contract Manufacturing Issues
Dasynoc; Xspray Pharma; FDA; Complete Response Letter; manufacturing issues; good manufacturing practice; contract manufacturer; chronic myeloid leukemia; acute lymphoblastic leukemia; drug approval process
About 5% of CBER and CDER Left After FDA Staff Cuts, Analysis Finds
FDA layoffs; CBER; CDER; drug review; biologics; staff cuts; Trump administration; drug approval process