Fiscal Year (FY) 2020 Generic Drug User Fee Amendments (GDUFA) Regulatory Science Initiatives Virtual Public Workshop

Fiscal Year (FY) 2020 Generic Drug User Fee Amendments (GDUFA) Regulatory Science Initiatives Virtual Public Workshop

The U.S. Food and Drug Administration (FDA) invites you to participate in the Fiscal Year (FY) 2020 Generic Drug User Fee Amendments (GDUFA) Regulatory Science Initiatives Virtual Public Workshop on May 4, 2020.

This science-focused workshop will provide an overview of the status of current FY 2020 GDUFA Science and Research Priorities.  FDA carefully considers the input provided at this workshop when we develop the FY 2021 GDUFA Science and Research Priorities, which 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.

Our GDUFA Science and Research program helps advance the science of generic drugs by investigating scientific issues that are encountered during review of regulatory submissions. The program also provides generic drug developers, applicants, and FDA reviewers essential tools and information that help expedite the availability of high-quality, lower-cost, safe, effective generic drugs.  

New opportunities at this year’s workshop:

• Virtual Attendance – the workshop will be offered via WebEx for all participants 
• Industry Leaders’ Roundtable – we will discuss the current landscape of FDA’s research program and get perspectives from industry leaders on various topics related to generic drug development.
• Breakout Sessions on the following topics:
• Post-Market Surveillance of Generic Drugs
• Drug-Device Combination Products
• In Vitro Bioequivalence Methods
• Data Analysis and Model-Based Bioequivalence

FDA seeks suggestions for generic drug research topics from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested parties. Submit your potential topics for the FY 2021 GDUFA Science and Research Priorities by emailing GDUFARegulatoryScience@fda.hhs.gov, or submitting suggestions to the public docket number FDA-2017-N-6644.

For more information about this workshop, please visit our meeting page, https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fy-2020-generic-drug-regulatory-science-initiatives-public-workshop-05042020-05042020.