Invitation to participate in FDA’s public workshop on generic drug regulatory science initiatives

The U.S. Food and Drug Administration (FDA) invites you to participate in the Fiscal Year (FY) 2019 Generic Drug Regulatory Science Initiatives Public Workshop on May 1, 2019. The FDA will give an overview of the status of current regulatory science initiatives for generic drugs and receive input from the public. 

The FDA’s generic drug regulatory science program investigates scientific issues that are encountered during the FDA’s review of generic drug regulatory submissions as well as potential scientific issues encountered prior to generic drug product application (pre-ANDA). This research is important to the development of product specific guidances and guidance for industry that can aid generic product development. Each year, the FDA holds this public workshop to solicit input on the development of its regulatory science initiatives for generic drugs, which is a requirement of the Generic Drug User Fee Amendments (GDUFA) and helps to further the mission of the generic drug regulatory science program.

The Agency is seeking input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information obtained from the public workshop into account in developing our FY 2020 regulatory science initiatives.

At this public workshop, we are particularly interested in receiving input regarding the following three topics: 

• Feedback on the current FY 2019 regulatory science initiatives including specific products or actions that FDA should consider as it implements these initiatives, 
• Newly approved new drug applications that may pose scientific challenges to the future development of generic products referencing those applications, and
• Regulatory science initiatives that FDA should begin to consider in FY 2020.

Participate 

The workshop will be held at FDA’s main campus in Silver Spring, Maryland, on May 1, 2019, from 8:30 am–4:30 pm and will be webcast for those who cannot attend in person.

Please submit requests to make oral presentations during your online registration by April 1, 2019. You may also suggest generic drug research topics that you recommend be added to the FY 2020 regulatory science initiatives by emailing GDUFARegulatoryScience@fda.hhs.gov.

Notify Us

If you wish to attend in person or via webcast, please email GDUFARegulatoryScience@fda.hhs.gov by April 1, 2019. The email should contain each attendee’s name, title, affiliation, address, email address, telephone number, and whether attending in person or by webcast. Those without email access can register by contacting Stephanie Choi (Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4736, Silver Spring, MD 20993, 240-402-7960) by April 1, 2019. If you need special accommodations because of a disability, please contact Stephanie Choi no later than April 1, 2019.