Articles tagged with “cmc-submissions”

FDA CGT Guidance 2026: Knowledge Reuse & CMC Submissions

Analyze the June 2026 FDA draft guidance on cell and gene therapies. Understand how reusing platform knowledge streamlines CMC submissions and development.

40 min read

5/16/2026

fda guidance cell and gene therapy cmc submissions platform knowledge genome editing regulatory affairs cgt development

AI in CMC Submissions: Process Analytics & Manufacturing

Examine the integration of AI in pharmaceutical CMC submissions and process analytics. Review QbD frameworks, regulatory guidelines, and manufacturing outcomes.

40 min read

4/8/2026

ai in pharma cmc submissions process analytics quality by design manufacturing intelligence continuous manufacturing digital cmc pat framework