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Accelerated Approval Should Be Less 'Wide Open,' Califf Says

 
• By Derrick Gingery

FDA should write more about its interpretation of regs and apply it more consistently across divisions, commissioner says.

FDA's standards for applying accelerated approval should not be "totally wide open," but also should not set a bright line for access to the expedited approval pathway, Commissioner Robert Califf said.

One of the unknowns with the use of accelerated approval is what amount of data constitutes "reasonably likely" to predict...

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Pink Sheet Podcast: US FDA Cuts Biosimilar Requirements, Clarifies Inspection Reform

 
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Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.

More from Pathways & Standards

Where RWE Studies Stand In India And Bharat Serums’ Plans For The World’s Largest One

 
• By Vibha Ravi

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Epilepsy Cell Therapy NRTX-1001 Among Trio Of Drugs To Win EMA PRIME Designations

 
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Tidmarsh Creates More Instability And Uncertainty For US FDA, Industry

 
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