- May 4, 2020
8:30 AM - 4:30 PM ET
- Date: Monday, May 4, 2020, from 8:30 - 4:30pm
- Location: FDA White Oak Campus, 10903 New Hampshire Ave. Bldg. 31, Rm. 1503 Sections B&C, Silver Spring, MD 20993
FDA will hold a science-focused public workshop to provide an overview of the status of the current FY 2020 Generic Drug User Fee Amendments (GDUFA) Science and Research Priorities as well as solicit input on the development of next year’s (FY 2021) priorities.
This workshop is an integral part of the agency’s GDUFA commitments. We carefully consider the input provided at the public workshop when we develop the FY 2021 GDUFA Science and Research Priorities. These priorities support product-specific guidance development, the review of Abbreviated New Drug Application (ANDA) submissions, and the pre-ANDA program outlined in the GDUFA commitment letter.
This year’s workshop introduces two exciting new opportunities:
- Industry Leaders’ Roundtable! Join us for a discussion with industry leaders about the current landscape of FDA’s research program and their perspective on FDA’s role in the development of generics.
- Breakout Sessions! There will be four concurrent breakout sessions on the following topic areas:
- Post-Market Surveillance of Generic Drugs
- Drug-Device Combination Products
- In Vitro Bioequivalence Methods
- Data Analysis and Model-Based Bioequivalence
FDA wants your input.
FDA seeks ideas on generic drug research topics from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested parties. You may submit your ideas for potential topics for the FY 2021 GDUFA Science and Research Priorities by emailing GDUFARegulatoryScience@fda.hhs.gov.
If you wish to attend (either in person or by webcast), please email the following information to GDUFARegulatoryScience@fda.hhs.gov:
- complete contact information for each attendee (i.e., name, title, affiliation, address, email address, telephone number)
- whether you (or other attendees) will be attending in person or by webcast
- which breakout session each person would like to attend (one per attendee)
When available, the Federal Register Notice, Meeting Agenda, and other details will be posted here.