- June 30, 2020
- Organized By:
Update as of 5/27/2020: The “Modernizing FDA’s Data Strategy public meeting originally scheduled to be held in-person will instead be held as a virtual-only meeting. Registration is required.
In September 2019, FDA announced its Technology Modernization Action Plan (TMAP). The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data and analytics—to advance FDA’s public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is scaled to respond to novel technologies and a rapidly increasing workload.
To achieve these goals, FDA will need an Agency-wide, strategic approach not only to technology, but to data itself. Data is at the heart of FDA’s work as a science-based Agency, and we anticipate ongoing, rapid increases in the amount and complexity of the data that informs FDA’s regulatory decision-making and public health mission.
The Food and Drug Administration (FDA or the Agency) is announcing a public meeting focused on possible Agency level approaches to data quality, data stewardship, data exchange, and data analytics.
The entrance for public meeting participants (non-FDA employees or contractors) is through Building 1, where routine security check procedures will be performed. For parking, security and other visitor information, please refer to Public Meetings at the FDA White Oak Campus.
Please use Eventbrite to register for webcast attendance.
If you need special accommodations due to a disability, please contact Jessica Berrellez, at 301-796-0511 or Jessica.Berrellez@fda.hhs.gov at least 7 days before the public meeting.
- Federal Register Notice for the March 27, 2020 public meeting
- Federal Register Notice for the June, 30, 2020 public meeting
- Draft agenda - subject to change
Live closed captioning content for FDA’s “Modernizing FDA’s Data Strategy” public meeting, held virtually on June 30, 2020.
Please note that due to the nature of live captioning, this may not be 100% accurate.
Regardless of attendance at the public meeting, you can submit electronic or written comments to the public docket by July 30, 2020. Submit electronic comments to Regulations.gov. Submit written comments to the Division of Docket’s Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. All comments must be identified with the docket number FDA-2019-N-5799. The FDA may post, without change, all comments received to Regulations.gov, including any personal information provided.