S. Maestro

Jul 17, 2024 | cellandgene.com | Antony Hitchcock |AGH Bioconsulting |A. Navarro |S. Maestro

FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine. Preparing For FDA Pre-Approval Inspection: Quality And Regulatory TopicsConsider these strategies for meeting quality and regulatory requirements in cell and gene therapies that can also help to identify issues early, reduce risks, and prevent delays and rework.