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The Quality Lowdown: Wishing Wished-For FDA Re-Inspections Had Gone Better?

 
• By Bowman Cox

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.

The Quality Lowdown

Inspection reports recently posted on the US Food and Drug Administration’s website suggest that pharmaceutical manufacturers are finally getting the follow-up inspections that could clear their manufacturing facilities for new brand and generic drug approvals, but which pandemic travel restrictions had delayed.

But not all the wished-for inspections went as well as might

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US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

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Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
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