FDA says manufacturers need robust shipping programs to ensure the safety and quality of cell therapies, since there are no ready replacements and a patient’s life can be at risk if problems arise. Kite exec notes that “more than any other biologic, the supply chain of autologous cell therapies reaches really literally end-to-end.”
FDA says that manufacturers should apply the same level of rigor to their storing and distribution programs as their development programs for cell therapy products. These are sensitive products that are highly dependent on cold temperatures for cells to survive and demand careful handling.
A series of speakers discussed some of the logistical challenges involved in distributing autologous cell therapies and the cryogenic conditions...
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
