FDA Avoided Half Of ANDA Pre-Approval Inspections During COVID By Using Alternative Tools
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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Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.
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.
CDER would lose the most money in the Senate appropriations bill compared to the House version, while CBER would see an increase.