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• Background
• Objective
• Attendance information
• Request for Oral Presentations
• Comments
• Contact

Background

Efficient and effective reviews of marketing applications are an important part of FDA’s mission to protect the public’s health by assuring the safety, efficacy, and security of drugs, biologics, and other medical products. To facilitate such reviews, FDA and Industry committed to improve communications between FDA and sponsors during drug development and application review as agreed upon under the Prescription Drug User Fee Act (PDUFA). Through PDUFA, FDA has established numerous meeting opportunities with sponsors such as Type A, B, and C meetings in addition to communications that take place during the review, such as mid-cycle telecons and late-cycle meetings. Two new meeting types, INTERACT and Type D meetings, were further added by the sixth reauthorization of PDUFA (PDUFA VII).

Objective

With the increased number and types of meetings and interactions, optimizing meeting management practices have become more important to facilitate the conduct of efficient and effective drug development programs. FDA contracted Eastern Research Group, Inc. (ERG) to conduct an internal assessment of the current state of meeting management and, to fulfill a commitment under the PDUFA VII commitment letter, data from this assessment will be discussed during this public workshop. After the presentation on data and findings, with the help of a moderator, FDA and Industry will share perspectives on the relevant data as it relates to meeting management good practices. Topics will include, but not be limited to, issues related to submission of meeting requests, efficient time management, coordinating meeting agenda, development and submission of meeting background packages and lessons learned from the Coronavirus Disease 2019 (“COVID-19”) pandemic including virtual meeting platforms.

Attendance information

This is an in-person/virtual hybrid event. The workshop is free to attend; however, registration is required for both in-person and virtual attendance. For those who wish to attend in person, the workshop will take place in the Great Room, Building 31, FDA White Oak Campus at 10903 New Hampshire Avenue, Silver Spring, MD. Registration for in-person attendance will close on July 8, 2024, 11:59 p.m. Eastern Time. Registration for the webinar will remain open until the day of the workshop. To register, visit https://fda.zoomgov.com/webinar/register/WN_2im_5zChQ8WvhX_kfS3CdQ.

Request for Oral Presentations

During online registration you may indicate if you wish to present during a public comment session. You must register online to present comments during the public workshop. All requests to make oral presentations must be received by the close of registration on July 8, 2024, 11:59 p.m. Eastern Time. There will be 20 minutes allotted for all public comments. Following the close of registration, FDA will do our best to accommodate requests to make public comments and will determine the amount of time allotted to each presenter. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the session. Public comments should answer the following question: Are there other best practices or recommendations that could improve the overall meetings process?

Comments

Please submit your comments regarding the workshop to Regulations.gov, Docket No. FDA-2024-N-2561 by August 22, 2024, 11:59 p.m. Eastern Time.

Contact

For questions regarding workshop content please contact:

Christopher Sese
Eastern Research Group, Inc.
561 Virginia Rd Suite 300 Building 4
Concord, MA 01742
Christopher.Sese@FDA.HHS.GOV

Danielle Villata
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Danielle.Villata@FDA.HHS.GOV

Sonday Kelly
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Sonday.Kelly@FDA.HHS.GOV

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