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Opioids Have Our Attention
June 21, 2018|Blog
Further Efforts to Repeal and Replace
June 20, 2018|Blog
ML Strategies Health Care Preview - June 18th
June 18, 2018|Blog
ML Strategies Health Care Preview - June 11th
June 11, 2018|Blog
ML Strategies Health Care Preview - June 4, 2018
June 4, 2018|Blog
A Rundown of Recent State Action Relating to Medicaid Expansion
June 4, 2018|Blog
FY2019 Massachusetts Budget Update: Final Senate Budget
May 30, 2018|Alert
News & Press Releases
Senior Director of ML Strategies Authors Article Published by MedCityNews on FDA’s Pre-Cert Program
June 12, 2019 | MedCityNews
On June 12, MedCityNews published an article authored by Senior Director of ML Strategies Aaron Josephson addressing challenges faced by the U.S. Food and Drug Administration (FDA)’s Pre-Certification (“Pre-Cert”) program. The Pre-Cert program would revolutionize regulation and oversight of certain medical devices.
In the article, Mr. Josephson remarks that, “establishing a new regulatory paradigm for complex medical technologies is no easy task.” The pilot program has already raised a number of concerns among smaller companies, including the high cost and value related to the number of products developed. Despite the preliminary issues and uncertainty from Congress, Mr. Josephson maintains that, “the FDA should be applauded for taking proactive steps to create a regulatory climate that balances innovation and safety.”
In the article, Mr. Josephson remarks that, “establishing a new regulatory paradigm for complex medical technologies is no easy task.” The pilot program has already raised a number of concerns among smaller companies, including the high cost and value related to the number of products developed. Despite the preliminary issues and uncertainty from Congress, Mr. Josephson maintains that, “the FDA should be applauded for taking proactive steps to create a regulatory climate that balances innovation and safety.”
Making a Statement (…or Not?) – A Q&A with Local PR Legend Nancy Sterling
April 25, 2019 | PRSA Boston
Nancy Sterling, Senior Vice President, Strategic Communications at ML Strategies, shares her insights around crisis communication in this Q&A with PRSA Boston Buzz.
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