Deconvoluting FDA Decisions Regarding Neurological Diseases

Date/Time: Tuesday, October 19, 2021 - 11:15 AM – 12:15 PM
Track: Interactive Workshop
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Description:

The FDA oversees the evaluation and potential approval of new pharmacologic products and medical devices. There has been a large increase in the number of medical devices approved for the treatment of neurologic conditions ranging from migraine to movement disorders. Similarly, new pharmacologic compounds are being investigated at a rapid pace, especially for neurodegenerative disorders. This workshop will review the FDA process, highlighting differences in the evidence required for a pharmacologic product vs. a device. Information will also be provided regarding serving as an expert in an FDA review panel. Finally, a discussion will be held on “close calls” and how convincing data need to be from the perspective of a clinician-scientist.

Chair: Seemant Chaturvedi, MD

Co-Chair: Johanna Fifi, MD

Objective(s):

  • Understand differences in the review process used by the FDA for drugs vs. devices

  • Appreciate the benefits and risks of serving on a FDA review panel

  • Appreciate the inside workings of an FDA submission

Crossing the Finish Line: Marathons and SPRINTS

Time: 11:15 AM – 12:15 PM

Moving Medical Devices to Patients in the US

Time: 11:15 AM – 12:15 PM

Serving on a FDA Advisory Committee: A Neurologist’s Perspective

Time: 11:15 AM – 12:15 PM