Using Alternative Tools, US FDA Avoided Half Of ANDA Pre-Approval Inspections During Pandemic
Records reviews are common now in lieu of an in-person inspection for US generic applications, but more virtual facility checks could be coming soon.
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US FDA Gets Less FY2022 Funding From Senate Than House, Different Inspection Priorities
CDER would receive $17m less in Senate appropriations bill compared to House veion, while CFSAN's total would be nearly $10m less. Overall, Senate bill includes around $50.4m less in funding for FDA than House bill.
Slump In Generic Submissions Helps US FDA Draw Nearly Even With Approvals
ANDA approval rates have remained steady, while submission rates dropped compared to prior years.
Remote Site Visits Will Help US FDA Keep Reviews On Track During Remainder Of Pandemic
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.