US FDA Freezes Inspections And Outside Meetings. Will Review Goal Dates Stay Put?
Sponsors have been asked to switch to teleconferences with FDA staff as the agency prepares for more of its employees to work from home.
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GCP Inspections: Corrective Measures For Adverse Findings Should Be Tested, US FDA Says
Sponsors, CROs and study investigators who receive an FDA Form 483 following a good clinical practice inspection should acknowledge the agency’s observations, explain the corrective actions planned, and how efficacy of those measures will be assessed, CDER officials say.
It Was Inevitable: FDA Inspection Delay Postpones BMS’s Liso-Cel Approval
Bristol Myers Squibb confirmed that approval for lisocabtagene maraleucel (liso-cel) will be delayed by the US FDA’s COVID-19-related restrictions on travel for manufacturing facility inspectors.
Approval Of BMS/Bluebird’s Ide-Cel May Come Just In Time
In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.