Webinars and Virtual Workshops

Webinars and Virtual Workshops Virtual Public Meeting on the Reauthorization of the Generic Drug User Fee Amendments (GDUFA) The FDA will hold a meeting to request public input on the reauthorization of the Generic Drug User Fee Amendments of 2017 for fiscal years 2023 through 2027 (“GDUFA III”). GDUFA authorizes FDA to collect user fees, which support the review of generic human drug applications, and creates a reliable funding source important to the agency’s continued ability to ensure timely review and approval of safe and effective high-quality generic drugs. Date: July 21, 2020      Time: 9:00 AM - 3:30 PM ET Registrants will receive instructions to access the live webcast of the virtual meeting. The webcast information, additional materials, and any other updates will be posted to FDA’s GDUFA website as they become available. Register Here Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. Date: July 22, 2020     Time: 12:15 PM - 1:15 PM ET Registration is not required.

Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA) The FDA is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027. Date: July 23, 2020     Time: 9:00 AM - 2:00 PM ET If you would like to attend the meeting, please register before June 23rd. Register Here WEBEX -Topical Drug Development Workshop - Evolution of Science and Regulatory Policy 2 The FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day virtual public workshop entitled, “Topical Drug Development - Evolution of Science and Regulatory Policy 2” on July 23-24, 2020. This workshop will bring together stakeholders from the FDA, academia, and industry to discuss recent advances in the assessment of dermal absorption using in vivo, in vitro, and in silico methods and models. The program will build upon the success of the predecessor workshop in 2019. Date: July 23 & 24, 2020     Time: 8:00 AM - 4:30 PM ET To register for this WEBEX, please visit the registration page. Register Here