CHPA Makes Take-Back Programs Top Policy Targets Outside Washington
CHPA will add its voice to the debate over local ordinances that include OTCs in mandatory drug take-back programs, says Carlos Gutierrez, senior director of state government affairs. Identifying the issue as its top non-federal policy fight, CHPA will continue working to educate consumers and support voluntary programs.
Learn what's happening at the US FDA. On the go.
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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.
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Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
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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.
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Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
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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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
