FY 2018 Generic Drug Regulatory Science Initiatives Public Workshop

Meeting Information


Thursday, May 24, 2018, from 8:30 - 4:30pm


FDA White Oak Campus, 10903 New Hampshire Ave. Bldg. 31, Rm. 1503 Sections B&C Silver Spring, MD 20993


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 reauthorization of the Generic Drug User Fee Amendments (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) 2019 Regulatory Science Plan. 

The workshop will be held on May 24, 2018, at the FDA White Oak Campus, 10903 New Hampshire Avenue Building 31, Great Room Sections B & C, Silver Spring, MD 20993. Additional details are available in the Federal Register Notice.

FDA wants your input. Electronic or written comments will be accepted at any time until the docket closes on June 25, 2018. 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.


If you wish to attend (either in person or by Webcast), please send an email to GDUFARegulatoryScience@fda.hhs.gov 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).

Meeting Materials:

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FY 2018 Generic Drug Research Public Workshop Presentations
Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance.


Session I: Evaluation of FY 18 Generic Drug Research Priorities

Session I: Evaluation of FY 18 Generic Drug Research Priorities

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