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Generic Review At US FDA: Record Month Completes Approval Volume Recovery

 
• By Derrick Gingery

With 96 full ANDA approvals and 30 tentative approvals, July was the most productive month since GDUFA launched.

Generics

Sponsors may be seeing the US FDA's ANDA assessment system running at full power once again, as it posted a record for full and tentative approvals in July.

Indeed, following a crash in approval volume in the second quarter, it now appears the recovery is complete and the...

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• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

More from Biosimilars & Generics

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
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Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

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