PhRMA and BIO give support for PDUFA VI performance goals

Pharmaceutical Research and Manufacturers of America

24 August 2016 - Both PhRMA and BIO have said they are pleased with the performance goals outlined by and for the agency from 2018 to 2022.

The US FDA released for comment a 46-page document last month outlining how the agency will use the user fees from industry, breaking down not only the planned deadlines for new guidance documents and pilot projects but also recurring themes of recent importance, including patient input to the regulatory process, use of real-world evidence, biomarker qualification and increased pharmacovigilance.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Timelines