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Hussain: Empowering Workers is the Key to Data Integrity

 
• By Bowman Cox

Why would pharmaceutical quality personnel fib about something like a batch test? Ajaz Hussain, the former FDA’er who helped launch the 21st Century Quality Paradigm, may have found the answer in the science of human behavioral economics.

Many Indian pharmaceutical companies need to strengthen their data integrity by changing their quality culture in ways that empower front-line workers, says Ajaz Hussain, an industry consultant, former FDA official and recognized authority on quality who early last year was working for one of India’s troubled drug makers.

During his FDA career, Hussain was a leader in FDA’s 21st Century cGMPs and process analytical technology initiatives, and he was the agency’s lead participant in the creation of the...

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• By Ewan Townsend

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Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
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More from Compliance

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
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Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
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