PMTA Deficiencies: The Most Common Reasons Applications Stall
August 25, 2026 Written by Austin Tyner Clinical [...]
Human Factors Is Now a Checkpoint in Every Device Submission
August 19, 2026 Written by Eric Jacobson Regulatory [...]
De Novo Classification: When It’s the Right Path and How It Works
August 5, 2026 Written by Austin Tyner Clinical [...]
Navigating the FDA 510(k) Process: A Step-by-Step Guide to Substantial Equivalence and Avoiding Common Pitfalls
July 28, 2026 Written by Austin Tyner Clinical [...]
FDA’s Draft MDUFA VI Agreement: What Device Makers Need to Know
July 21, 2026 Every [...]
FDA Proposes Drug Manufacturing Registration Rule
July 17, 2026 On [...]
Switching Studies for Vapes: How Age-Gating Changed the Calculus
July 16, 2026 Written by Dr. Vincent Angelico [...]
Do Nicotine Pouch Applications Need a Switching Study?
July 10, 2026 Written by Dr. Vincent Angelico [...]
What The Annual National Youth Tobacco Survey (NYTS) Means for Brands’ PMTA Strategies
July 7, 2026 Written by Austin Tyner Clinical Review [...]
