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  4. FDA-NRC Workshop Enhancing Development of Novel Technologies: Radiopharmaceuticals and Radiological Devices - 10/14/2020 - 10/14/2020
  1. News & Events for Human Drugs

Workshop | Virtual

Event Title
FDA-NRC Workshop Enhancing Development of Novel Technologies: Radiopharmaceuticals and Radiological Devices
October 14, 2020

Date:
October 14, 2020

Recorded Webcast: https://nrc.rev.vbrick.com/#/videos/16b33d7a-1480-4500-a074-03e7a6c8a257

Transcript: https://www.nrc.gov/docs/ml2032/ML20325A090.pdf  

Presentation Slides

Q&A Submissions

Topics 

  • 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

Meeting Materials

Agenda (PDF - 122KB)

Contact

For additional details, contact

Technical Contacts:
Frank Lutterodt, Project Manager, DIRM,
FDA Frank.Lutterodt@fda.hhs.gov
Lisa Dimmick, Team Leader, Medical Radiation Safety,
U.S.NRC Lisa.Dimmick@nrc.gov
Meeting Logistics: Sarah Lopas Sarah.Lopas@nrc.gov

 

Event Materials

Title File Type/Size
AgendaCollaborativeWorkshipFDA-NRC_pdf pdf (137.58 KB)
Session IV Slides pdf (14.76 MB)
Session II Slides pdf (7.26 MB)
Session I Slides pdf (5.28 MB)
Session V Slides pdf (880.54 KB)
Session III Slides pdf (1.15 MB)
Chat Questions pdf (71.00 KB)
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