FDA will hold a public workshop that will provide an overview of the current status of the regulatory science initiatives for generic drugs and will provide an opportunity for public input on research priorities in these topic areas. FDA is seeking input from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested parties––as it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing the fiscal year (FY) 2018 Regulatory Science Plan.
The workshop will be held on May 3, 2017, at the FDA White Oak Campus, 10903 New Hampshire Avenue Building 31, Great Room Sections B & C, Silver Spring, MD 20993. Full details are available in the Federal Register Notice.
FDA wants your input. Submit electronic or written requests to make oral presentations no later than April 5, 2017. Electronic or written comments will be accepted at any time until the docket closes on June 2, 2017. You may also submit ideas on generic drug research topics to be included on the FY 2018 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov. FDA will do its best to accommodate requests to make public comments.
If you wish to attend (either in person or by Webcast), please email to GDUFARegulatoryScience@fda.hhs.gov by April 5, 2017. 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).
Information on previous public meetings can be found on the GDUFA Regulatory Science website (see "Part 15 Public Meetings").
Wednesday, May 3, 2017
8:30 a.m. to 4:30 p.m.
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (Great Room)
Silver Spring, Maryland 20993
If you will be attending the public workshop in person, please review the new security procedures and parking at the White Oak campus. Please note all visitors must enter through Building 1 and check in through security. If you will be driving a personal vehicle, please go through the vehicle screening facility and park in one of the designated visitor parking lots.
Additional meeting materials, including presentation slides, will be posted in the coming weeks.