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Don’t Panic: The FDA’s Guide To Saving Drug Approvals From Suspect Data

 
• By Bowman Cox

Drug approvals can survive manufacturing data integrity failures, US FDA official says. Here’s how.

Don't panic
fda: don't panic, make a plan. A global plan. • Source: Wikimedia Commons

It can end badly when the US Food and Drug Administration learns it has approved drugs based on suspect manufacturing data – but it doesn’t have to if companies keep their cool and take certain key steps that an agency official recently described.

The official, Derek Smith, outlined the process for remedying such situations when he spoke at the recent Drug Information Association annual meeting in San Diego, CA. Smith oversees the division...

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