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FDA Disruption, Data Expectations, and What Actually Matters – 1/15/26
In the first episode of Trying to Keep Up, Michael Nilo and Allison Komiyama unpack the evolving regulatory landscape at the FDA, from workforce disruptions to shifting expectations around clinical data and submission strategy.
They cut through the noise to focus on what impacts medtech teams right now: how review dynamics are changing, where risk is increasing, and how companies can stay proactive instead of reactive.
This is not a scripted podcast. It’s a working conversation between two regulatory professionals trying to keep up in real time.
Key Topics Covered:
- FDA workforce reductions and operational impact
- Shifts in review consistency and timelines
- Clinical data expectations vs. historical precedent
- Where sponsors underestimate regulatory risk
- How to use Q-Submissions strategically
- Practical ways to stay ahead of uncertainty
Stay Connected:
- Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
- Michael Nilo, MS | Nilo Medical Consulting Group
Subscribe:
- Sign up to receive a calendar invite for weekly TTKU sessions
- YouTube
- Spotify
- Apple Podcasts
View all episodes
By TTKUIn the first episode of Trying to Keep Up, Michael Nilo and Allison Komiyama unpack the evolving regulatory landscape at the FDA, from workforce disruptions to shifting expectations around clinical data and submission strategy.
They cut through the noise to focus on what impacts medtech teams right now: how review dynamics are changing, where risk is increasing, and how companies can stay proactive instead of reactive.
This is not a scripted podcast. It’s a working conversation between two regulatory professionals trying to keep up in real time.
Key Topics Covered:
- FDA workforce reductions and operational impact
- Shifts in review consistency and timelines
- Clinical data expectations vs. historical precedent
- Where sponsors underestimate regulatory risk
- How to use Q-Submissions strategically
- Practical ways to stay ahead of uncertainty
Stay Connected:
- Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
- Michael Nilo, MS | Nilo Medical Consulting Group
Subscribe:
- Sign up to receive a calendar invite for weekly TTKU sessions
- YouTube
- Spotify
- Apple Podcasts