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More Than 100 Applications Lost Equivalence Rating Thanks To Allegedly Falsified Data At Two CROs

 
• By Derrick Gingery

Sponsors must decide whether to repeat bioequivalence and other studies after two CROs were found to have potentially falsified data, causing the US FDA to reject all data produced by the firms.

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Because the data integrity of some studies came into question, the FDA said all data from two CROs was not reliable. • Source: Alamy

More than 100 to potentially 200 generic drug applications have been downgraded to a not substitutable rating after the US Food and Drug Administration uncovered a substantial data integrity problem at two contract research organizations, forcing sponsors to scramble to restore their products’ prior status.

Suspect pharmacokinetic studies at Synchron Research Services of Ahmedabad Gujarat, India and Panexcell Clinical Lab, of Navi Mumbai, India raised the concerns. In the Synchron case, investigators found a notebook...

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

 
• By Sarah Karlin-Smith

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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US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
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Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

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More from Biosimilars & Generics

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

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EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.