Meeting Details
Category 3Time Change
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
Webinar
Documents
| Document Title | Description |
|---|---|
| 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/
In addition to WebEx, a live webcast of the workshop WebEx will be available at https://video.nrc.gov/
Participants
Office of Nuclear Material Safety and Safeguards
External Participants
US Food and Drug Administration
Contact
Sarah Lopas, NRC
(301) 415-6360
Lisa Dimmick, NRC
(301) 415-0694