CHPA says CBO's five-year $232m estimate for the costs of compliance with the DXM Abuse Prevention Act is too high since it is based on costs of FDA's tobacco compliance check program. CBO says the bill would have a minimal cost impact on retailers, since many already restrict sales.
The Consumer Healthcare Products Association contends the Congressional Budget Office made a flawed comparison to FDA's Tobacco Retail Compliance Check program when it estimated federal costs from age-restricting sales of dextromethorphan-containing OTC drugs.
To determine its estimate of $232m over five years for the costs of enforcing a ban Congress is considering on...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
