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ML Strategies October 2018 Election Update
October 10, 2018|Advisory
Celebrating the Promise of Parity and the Path Forward
October 9, 2018|Blog
ML Strategies Weekly Health Care Preview - Week of September 24th
September 24, 2018|Blog
ML Strategies Health Care Preview - Week of September 17th
September 17, 2018|Blog
ML Strategies 2018 Election Preview
September 11, 2018|Advisory
ML Strategies Weekly Health Care Preview – September 10, 2018
September 10, 2018|Blog
ML Strategies Capitol Hill & Executive Branch Fall Preview
September 6, 2018
ML Strategies Health Care Preview – Week of September 4th
September 4, 2018|Blog
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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