Workshop | Mixed
Event Title
Public Workshop: Best Practices for Meeting Management Under PDUFA VII
July 22, 2024
- Date:
- July 22, 2024
- Time:
- 9:00 a.m. - 2:00 p.m. ET
- Background
- Objective
- Attendance information
- Request for Oral Presentations
- Comments
- Contact
- Event Materials
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.
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