News & Insights
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News
Understanding the Regulatory Framework for OTC Drugs in the United States
April 9, 2025 Over-the-counter (OTC) drugs play a vital role in public health by providing consumers with access to safe and effective treatments for common conditions without requiring a prescription. [...]
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 [...]
Insights
FDA Granted Regulation of Synthetic Nicotine: What You Need to Know
FDA Granted Regulation of Synthetic Nicotine: What You Need to Know US Government is Redefining "Tobacco Products" On March 15th, 2022 President Biden signed the omnibus spending bill [...]
Don’t Just Win a PMTA Battle, Win the PMTA War
Don't Just Win a PMTA Battle, Win the PMTA War At Accorto Regulatory Solutions, we work with companies who are pushing back on the FDA’s arbitrary and wholesale issuance of Market Denial [...]
New Bill Aims to Regulate Synthetic Nicotine in 2022
New Bill Aims to Regulate Synthetic Nicotine in 2022 On December 15, 2021, Congresswoman Mikie Sherrill from New Jersey announced the introduction of the “Clarifying Authority Over Nicotine Act of 2021”. [...]
