XGene Real-Time Regulatory Intelligence™

FDA’s Draft Guidance on Leveraging Prior Knowledge for Genome Editing Gene Therapies — The CMC Precedent-Sharing Framework Every GT Program Should Map Before September 1

FDA/CBER’s new draft guidance on leveraging prior knowledge for genome editing gene therapies is the first framework distinguishing which CMC attributes are eligible for platform-based leveraging versus product-specific — comments close September 1, 2026.

FDA’s Draft Guidance on Leveraging Prior Knowledge for Genome Editing Gene Therapies — The CMC Precedent-Sharing Framework Every GT Program Should Map Before September 1 Read More »

Babikian Healthcare Products Added to Import Alert 66-40: The CGMP Pattern Behind the Detention and What Every Quality Director Managing Dietary Supplement and OTC Drug Sites Must Know

FDA added Babikian Healthcare Products to Import Alert 66-40 with a blanket Detention Without Physical Examination across its entire drug product line — with no companion Warning Letter publicly available to explain the underlying finding.

Babikian Healthcare Products Added to Import Alert 66-40: The CGMP Pattern Behind the Detention and What Every Quality Director Managing Dietary Supplement and OTC Drug Sites Must Know Read More »