Bioequivalence Study Interruptions Not Just A Coronavirus Problem
US FDA should create a policy to help save troubled studies, because failure can kill generic development programs, Lachman Consultants’ Michelle Ryder suggests.
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New drug approvals dropped, likely because of a new focus on COVID-19 treatments, while generic drug approvals increased.
Agency emphasizes feasibility and consistency when it comes to remote administration of clinician-reported and performance outcome assessments in studies disrupted by the pandemic; latest guidance update also discusses remote site monitoring, as well as alternative procurement and administration of investigational products.
Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.