A study the Consumer Healthcare Products Association commissioned finds OTC access to the cough suppressant dextromethorphan will save consumers between $22bn and $31bn through 2025 compared to a scenario of the product moving to Rx-only.
Continued OTC access to the cough suppressant dextromethorphan, compared to making the ingredient prescription-only, would save as much as $31bn in drug and other health care costs through 2025, according to a Consumer Healthcare Products Association study.
Conducted by Charles River Associates consultancy, the “Managing Access to Dextromethorphan: Cost Implications of a Potential Over-the-Counter to Prescription Only...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
