Pharmaceutical industry groups want more direction on how non-direct trading partners will be notified that a drug has been granted a waiver, exception or exemption (WEE) request under DSCSA so that good product is not deemed suspect and thrown out. There were also calls to expand the list of drugs eligible for exemption to include temperature-sensitive drugs as well as orphan drugs.
Pharmaceutical industry groups want more clarity on how non-direct trading partners will be notified that a drug has been deemed eligible for a waiver from complying with the tracking requirements under the Drug Supply Chain Security Act (DSCSA) so they won’t throw it out for failure to receive notification.
Another suggestion groups made in comments on draft guidance was for FDA to estimate the typical length of time it...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
