“Difficult” Bioequivalence Issues Make Limited Progress At Advisory Cmte.
If the July 23 meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee is any indication, FDA appears years away from changing approval standards for generics of drugs with complex dosage forms.
Learn what's happening at the US FDA. On the go.
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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.’
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