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That’s The Way The Tablet Crumbles: Industry Protests FDA Friability Test

 
• By Martin Berman-Gorvine

A split tablet’s structure is compromised by definition and shouldn’t be subjected to friability testing, drug manufacturers argue in response to an FDA draft guidance.

FDA should not impose the proposed friability testing standard for tablets designed to be split, industry commenters said in response to an August draft guidance.

The draft recommends that “tablet splitability at both ends of the proposed hardness range should be demonstrated by: (1) Ensuring...

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

 
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Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
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PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
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