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
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, 8AM - 5PM EDT
Meeting Location
Webinar
Webinar
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
In addition to WebEx, a live webcast of the workshop WebEx will be available at https://video.nrc.gov/