Return To Sender, Industry Groups Say Of AER Address Guidance
FDA's recommendation for complete addresses on OTC and dietary supplement product labels in order to comply with the adverse event reporting law exceeds not only Congress's intent, but also the requirements for all other products regulated by the agency, industry groups say
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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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