Insights That Move You Forward
Helping you make smarter decisions, avoid costly missteps, & bring safe, effective products to market with confidence
MedTech Regulatory Risk: Navigating the FDA During a Government Shutdown
When the U.S. government shuts down, FDA operations slow—and medical device companies can face costly delays. In this Global Medical Device Podcast Q&A, NMCG President and former FDA Scientific Reviewer Michael Nilo explains what continues, what stops, and how MedTech leaders can strategically navigate the disruption.
How a Government Shutdown Affects FDA Medical Device Regulation
Government shutdowns don’t completely stop the FDA—but they do create unpredictability. While essential functions like recalls and safety monitoring continue, new submissions, inspections, and policy development often stall. Learn what history tells us about shutdown impacts and how device makers can prepare.
What to Expect from an FDA Pre-Submission Meeting
FDA Pre-Submission meetings offer critical insight into regulatory expectations before you invest time and budget. From strategy planning to meeting facilitation, NMCG helps sponsors maximize feedback, reduce delays, and approach FDA reviewers with confidence and clarity.
CRO vs. Consulting Firm: What’s the Difference and Why It Matters
Success in clinical development depends on knowing when to engage a CRO and when to rely on a consulting firm. CROs excel at executing trials with precision, while consulting firms guide strategy, submissions, and compliance. Understanding the difference—and when you need both—can mean the difference between costly delays and streamlined market approval.