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Arizona 1115 Medicaid Waiver Update
January 22, 2019|Blog
ML Strategies Health Care Preview - Week of January 22nd
January 22, 2019|Blog
The Buzz About Block Grants
January 16, 2019|Blog
ML Strategies Health Care Preview - January 14, 2019
January 15, 2019|Blog
ML Strategies Health Care Preview - Week of January 7, 2019
January 7, 2019|Blog
ML Strategies Weekly Preview - December 17, 2018
December 17, 2018|Blog
What's Next After the Texas vs. Azar Ruling?
December 17, 2018|Blog
Transportation & Infrastructure in the 116th Congress
December 17, 2018|Advisory
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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