FDA latest sunscreen guidances incorporate little industry input and are met with frustration and hope among industry stakeholders. The PASS Coalition and the Natural Products Association weigh in on future cooperation between FDA and industry under SIA.
The sunscreen product industry will ask FDA, after it failed to acknowledge stakeholders' suggestions in four guidances required by the Sunscreen Innovation Act, to allow flexibility it has said is available for showing that additional ingredients are appropriate for the US market.
FDA on Nov. 22 published the final two SIA-required guidances, including one on the content and format 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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
