Slump In Generic Submissions Helps US FDA Draw Nearly Even With Approvals
Agency Publishes Data For First Half Of Current Fiscal Year
ANDA approval rates have remained steady, while submission rates dropped compared to prior years.
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US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.
Details of how the FDA plans to conduct remote evaluations of manufacturing facilities during the COVID-19 pandemic have been set out in guidance published by the US agency.
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.