Come to FDA’s GDUFA Regulatory Science Initiatives Public Meeting

FDA is hosting the Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting to give an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on the FY 2016 research priorities.

FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public meeting into account in developing the fiscal year (FY) 2017 Regulatory Science Plan.

The meeting will be held at FDA’s main campus in Silver Spring, MD, on May 20, 2016, from 9:00am-5:00pm and will be webcast for those who cannot attend in person.

Submit electronic or written requests to make oral presentations and comments by April 29, 2016. Electronic or written comments will be accepted at any time until the docket closes on June 17, 2016 You may submit ideas on generic drug research topics that should be added to the FY 2016 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov.

If you wish to attend, either in person or via webcast, or present at the hearing, please email GDUFARegulatoryScience@fda.hhs.gov by April 29, 2016. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, telephone number, and whether you will be attending in person or by webcast). Those without email access can register by contacting Thushi Amini (Thushi.Amini@fda.hhs.gov) by April 29, 2016. If you need special accommodations because of a disability, please contact Thushi Amini at least seven days before the hearing.

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