US FDA Assesses Over 500 Biopharma Plants Remotely Via Records Review; Refines Process
Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.
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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.
How FDA Will Use Its New Authority against Denying, Limiting or Refusing Inspections – And Why Industry is Still Worried
How will FDA use its recently drafted guidance against obstructing inspections? Industry fears it may depend on how individual investigators interpret terms like “reasonable.”
Under pressure to authorize use of Lilly’s bamlanivimab, the FDA must first weigh efficacy signals and GMP plant remediation progress.