News & Insights
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News
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 [...]
Navigating the Intersection of Patent Law and Regulatory Strategy for Medical Device Companies
March 4, 2025 | Expert Insights | Authored by Accorto Regulatory Solutions & Ward Law Office Inventors of new medical technologies often face a myriad of decisions when beginning the [...]
Understanding the Role of Risk Assessments for FDA Regulatory Submissions: A Key Step in Medical Device Success
November 15, 2024 | Regulatory Insights | Author: Neel Parmar For a successful FDA submission in the US medical device industry, demonstrating the safety and efficacy of your product is [...]
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 [...]
