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US FDA public meeting on June 15 on reauthorisation of GDUFA

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FDA has invited public suggestions on the GDUFA programme and the features FDA should propose for the next programme

FDA will hold a public meeting on June 15 to seek input on the reauthorisation of the Generic Drug User Fee Amendments of 2012 (GDUFA) as the legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years.

A release from the FDA invites public comment on the GDUFA programme and to provide suggestions regarding the features FDA should propose for the next GDUFA programme, especially on the assessment of the overall performance of the GDUFA programme to date and aspects of GDUFA that should be retained, changed, or discontinued to further strengthen and improve the programme.

FDA will consider written comments received to the public docket up to 30 days after the public meeting and will publish the comments on FDA’s website. The comment period to the public docket is currently open and will remain open until July 15, 2015. For registrations, information needs to be emailed to [email protected] by June 1, 2015.

EP News BureauMumbai

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