NEWS & VIEWS
FDA Says Only One Pivotal Clinical Trial Now Required for New Drug Approval
Additional Confirmatory Evidence Will Still Be Expected
FDA Releases Nearly 300 Complete Response Letters in 2025 – CMC Issues Found to Be the Main Reason for BLA/NDA Rejection
FDA Releases Nearly 300 Complete Response Letters in 2025 – CMC Issues Found to Be the Main Reason for BLA/NDA Rejection
Big Changes Coming for INDs, BLAs, & NDAs (Module 3 and Module 2.3)
First Major Revisions to the Common Technical Document (CTD) CMC Section Guidance in 25 Years