US FDA Assesses Over 500 Biopharma Plants Remotely Via Records Review; Refines Process
Executive Summary
Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.
You may also be interested in...
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.
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.”
US Buy Of Lilly’s COVID-19 Therapy Now Turns On FDA's Manufacturing Quality Assessment
Under pressure to authorize use of Lilly’s bamlanivimab, the FDA must first weigh efficacy signals and GMP plant remediation progress.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: