Panel: Untangling FDA Requirements for CQAs in IND Applications for Cell Therapy Products
Time: 2:30 pm
day: Cell Therapy Focus Day
Details:
• Describing expectations from the FDA on how to maintain CQAs after a method or product change in development of cell therapies
• Avoiding common shortcomings with comparability assessments when presented to FDA regulators
• Applying advice to future development and comparability strategies
