Jan 31, 2022
Tim Marjenin is the Vice President of Neurology Regulatory Affairs at MCRA where he helps neurotech companies get through the challenges of being approved by the FDA. Tim has had over 16 years in the regulatory side of things before now advising the companies.
Top 3 Takeaways:
0:45 "Do you wanna describe yourself a little bit? "
2:45 "What does the day-to-day look like in the FDA?"
5:30 "So for those that don't know, what is the FDA review process look like? How many people are reviewing it, what's the timeline?"
7:45 "How many people are involved in this whole process, is the weight of millions of people's lives resting on one person's shoulders, or is it more like a committee?
9:30 "What do you do at MCRA?"
10:45 "How has your job changed?"
13:45 "You wanted to share some successes that maker has had, do you want to talk about these?"
15:30 "What does it mean to get a de novo status?"
19:00 "What's timeline from start to finish for your guys' work?"
20:30 "What are some things that people do that they shouldn't do?"
23:00 "Is there anything that we didn't talk about that you wanted to mention? "