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Risk-Based Inspections Might Actually Be Hurting Compliant Firms

 
• By Derrick Gingery

Industry exec asks FDA to help good manufacturers prove to other countries they continue to meet GMPs even if they are not inspected frequently.

FDA’s risk-based inspection program may be hurting some of the most compliant generic drug manufacturers because they might not be inspected as frequently as necessary to maintain compliance in other countries.

Without a change in the inspection volume or some other FDA assurance of compliance, finished dosage form authorizations could be...

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• By Alaric DeArment and Cathy Kelly

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• By Cathy Kelly

The issue is attracting more attention as the 2028 deadline for implementing Medicare negotiated prices for Part B drugs approaches.

‘Missed Opportunity’: GSK Failed To Optimize Blenrep Dosage, US FDA Panel Says

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee said the benefit-risk of belantamab mafoditin for two second-line multiple myeloma indications is not favorable at the proposed dosages and raised concerns about applicability of trial results to US patients.