US FDA officials told manufacturers to beware of using reused solvents and catalysts to avoid carcinogenic impurities such as nitrosamines from leaching into valsartan and other ARBs used to treat high blood pressure. FDA has identified 40 nitrosamine-free ARBs to provide alternatives to patients and health care providers experiencing shortages caused by recent recalls of these products.
US FDA officials told manufacturers that nitrosamine impurities can form during processing of active pharmaceutical ingredients in making angiotensin II receptor blockers (ARBs) when raw materials such as solvents and catalysts are used on equipment that has not been cleaned or if these materials have been recycled or reused.
The agency also advised manufacturers of these products to test a representative sample for batches produced for the US market...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
