FDA’s latest drug shortages task force aims to encourage investment in the reliable manufacture of generic sterile injectables that are fundamental to the practice of medicine. While the agency’s first task force continues to work with industry to avert shortages, the second will strike at underlying structural issues that cause persistent shortages of these critical medicines.
A second US FDA drug shortages task force is casting a wider net to resolve chronic shortages of critical generic sterile injectables by helping to increase profitability and decrease supply chain risks.
The recently announced task force will, for example, work with government payers to review reimbursement policies that discourage manufacturing of...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
