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Meeting info
Purpose
The objectives of this FDA-NRC workshop are: 1) Develop collaborative approaches among stakeholders in development of new drug products and devices with emphasis on addressing unmet medical needs for serious and life-threatening conditions. 2) Expedite regulatory reviews and increase the overall efficiency of the development process to ensure timely access for patients to emerging therapies. Topics for Discussion: -Overview of Regulatory Process for Marketing and Licensing of Radiopharmaceutical Devices -Novel Radiopharmaceuticals: physical standards development, product quality considerations, supply and demand -Safety and Efficacy Considerations for Radiopharmaceutical Products -The Evolving Landscape—Radiological Devices -Clinical Trial Design Considerations for Radiopharmaceuticals Please see the FDA's Website for additional information: https://www.fda.gov/drugs/news-events-human-drugs/fda-nrc-workshop-enhancing-development-emerging-technologies-radiopharmaceuticals-and-radiological
Meeting Feedback
Meeting Dates and Times
* Date/Time Change *
10/14/20
8:00AM - 5:00PM

Webinar
Webinar Link:https://usnrc.webex.com/usnrc/onstage/g.php?MTID=eabeba69a55ff5fc6faf8d90db0b2e450
Webinar Meeting Number:199 171 3631
Webinar Password:FDA-NRC
Contact
Sarah Lopas, NRC
(301) 415-6360

Lisa Dimmick, NRC
(301) 415-0694

Participation Level
Category 3
NRC Participants
Office of Nuclear Material Safety and Safeguards
External Participants
US Food and Drug Administration
Docket Numbers - Facility Names
Related Documents
ML20281A547 - Agenda for October 14, 2020 Collaborative Workshop FDA-NRC: Enhancing Development of Novel Technologies - Radiopharmaceutical and Radiological Devices

ML20283A345 - 10/14/2020 U.S. Food and Drug Administration (FDA) and U.S. Nuclear Regulatory Commission (NRC) WorkshopEnhancing Development of Novel Technologies: Radiopharmaceuticals and Radiological Devices

Comments
The October 14th workshop will be conducted using Cisco WebEx. To participate in the workshop, please pre-register using the webinar link provided above. In addition to WebEx, a live webcast of the workshop WebEx will be available at https://video.nrc.gov/

Page Last Reviewed/Updated Friday, November 19, 2021

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