The Quality Lowdown: Wishing Wished-For FDA Re-Inspections Had Gone Better?
As the COVID-19 pandemic wore on, industry clamored for the US FDA to re-inspect troubled drug manufacturing plants remotely if need be to clear them for new approvals. Now FDA investigators are out in force and early returns from Sun, Aurobindo, Lupin and Sterling suggest these re-inspections will be as tough as ever.
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Agency conducts follow-up inspection as Aurobindo's Polepally, India, manufacturing facility looks to move on from crippling OAI designation.
After years of pandemic-related delays, US FDA reinspects key Sun plant in Halol, India, hit with “official action indicated” inspection findings that tabled approvals just before COVID-19 impeded travel. However, new findings are generating further discussions.
Keeping Track: US FDA Clears Vtama, But Not Bimekizumab Or Ycanth; Tibsovo Takes RTOR To Frontline AML Setting
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.