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Manufacturing Problems Aren't Rising, But It Was A Hot July

 
• By Bowman Cox

Lack of readiness derails eye drugs from Valeant and Ocular, which now must convince FDA they know what they are making; meanwhile, an expert shares how mistake-proofing processes can help.

FDA's rejection of two applications for new eye drugs in the past week resulted from failures to demonstrate manufacturing readiness. Such failures are the most common reason for manufacturing-driven complete response letters (CRLs), agency investigators say.

In recent years, manufacturing issues accounted for at least one of every five CRLs, according to the Pink Sheet's FDA...

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• By Sarah Karlin-Smith

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UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
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