CDC’s director signs off on FDA’s proposed updates to COVID-19 vaccines, marking the country’s second attempt to simplify the administration schedule in a effort to increase vaccine uptake. There’s little evidence that this latest strategy shift will be any more successful.
The US cleared older Americans and people who are immunosuppressed to get additional COVID-19 bivalent boosters 19 April, coupling those changes with new “simplified” vaccine guidelines for all Americans that will eliminate the use of the original monovalent mRNA vaccines from Pfizer Inc. and Moderna, Inc..
The Centers for Disease Control and Prevention Director Rochelle Walensky signed off on the Food and Drug Administration’s plan, which...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
