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The Quality Lowdown: ICH Q9, FDA QMM, THC Impurities And Recertified MAPPs

 
• By Bowman Cox

Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.

The Quality Lowdown

Regulatory issues may wax and wane, but useful insights can surface along the way that may serve as guideposts for the regulated community.

The International Council on Harmonisation’s original Q9 guideline on risk assessment has drawn criticism over the years as too high-level...

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Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 
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With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
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ICH Proposes Global Framework For Managing Leachables In Pharma Products

 
• By Vibha Sharma

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• By Anabel Costa-Ferreira

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Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

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• By Sue Sutter

The Pink Sheet viewed Stealth's complete response letter and other documents indicating the FDA appears willing to grant accelerated approval to elamipretide before a confirmatory trial begins enrolling. But the company says it needs a two-month review of the NDA resubmission to survive.