News & Insights
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News
FDA Changes in Motion: A Live View of Staff, Structural, and Policy Changes Under the New Administration
With a new administration comes a fresh wave of changes at the FDA, bringing shifts in leadership, policy priorities, and regulatory approaches. These adjustments will impact a wide range of industries, from medical devices [...]
Texas Judge Strikes Down FDA Laboratory Developed Test Final Rule
April 1, 2025 On Monday, a federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May [...]
Breaking New Ground: What ZYN’s FDA Approval Means for the Future of Nicotine Pouches
March 21, 2025 | Expert Insights The recent approval of ZYN nicotine pouches by the U.S. Food and Drug Administration (FDA) on January 16, 2025, marks a pivotal moment for [...]
Insights
The FDA Deficiency Letter Response Process for Premarket Tobacco Applications: How to Survive Substantive Scientific Review
The FDA Deficiency Letter Response Process for Premarket Tobacco Applications: How to Survive Substantive Scientific Review The Substantive Review Process: Once a premarket tobacco application has been accepted [...]
Your Vape PMTA & FDA’s New Consumer Research Guidance
Your Vape PMTA & FDA's New Consumer Research Guidance On Oct 27, FDA’s Office of Science and Office of Regulation in the Center for Tobacco Products released new guidance for [...]
Understanding Vape PMTA Statuses
Understanding Vape PMTA Statuses If you’re following PMTA submissions, you’ve probably seen many press releases from vape companies detailing the status of their applications. The FDA review process has multiple [...]
