News & Insights
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News
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 [...]
What is FDA’s Standard of Appropriate for the Protection of Public Health?
July 30, 2024 - The following article was developed by Inter Scientific CEO, David Lawson, in collaboration with Accorto's Cheif Science Officer, Dr. Vince Angelico Introduction Those familiar with the Premarket Tobacco Product (PMTA) pathway, [...]
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”. [...]
