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US FDA Expands KASA Platform To Probe API Synthesis, Conduct NDA Quality Reviews

 
• By Bowman Cox

Agency builds on success with last year’s KASA-based ANDA quality reviews to widen and deepen the software tool’s functionality, says CDER OPQ leadership. CMC assessors are adapting quickly to a platform that could soon alert them to issues like possible genotoxic impurity formation during API synthesis.

pharmaceutical analytics
kasa will enable quicker, more insightful assessments. • Source: Shutterstock

Later this year, the US Food and Drug Administration plans to expand its use of a new quality assessment platform to include not just generic drug applications but also active pharmaceutical ingredient drug master files (DMFs), and new drug applications (NDAs).

The agency last year used the Knowledge-Aided Assessment and Structured Application platform in reviewing more than 500 generic drug applications...

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US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
• By Michael McCaughan

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

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UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

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

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

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EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
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The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.