FDA Pauses Overseas Genetic Engineering Trials: What It Means for the Industry
June 19, 2025 On June [...]
Modernizing U.S. Cosmetic Regulation: A Guide to MoCRA
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Understanding Medical Device Classifications: A Guide for Medical Device Innovators and Manufacturers
May 13, 2025 When beginning [...]
PMTA vs. STN: Understanding the Regulatory Process for Nicotine Products
April 23, 2025 | Expert Insights [...]
Understanding the Regulatory Framework for OTC Drugs in the United States
April 9, 2025 Over-the-counter (OTC) [...]
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 [...]
Texas Judge Strikes Down FDA Laboratory Developed Test Final Rule
April 1, 2025 On Monday, [...]
Breaking New Ground: What ZYN’s FDA Approval Means for the Future of Nicotine Pouches
March 21, 2025 | Expert Insights [...]
Navigating the Intersection of Patent Law and Regulatory Strategy for Medical Device Companies
March 4, 2025 | Expert Insights | Authored by [...]
Understanding the Role of Risk Assessments for FDA Regulatory Submissions: A Key Step in Medical Device Success
November 15, 2024 | Regulatory Insights | Author: Neel [...]
