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What Does the Future Hold for Drug Pricing?
February 28, 2019|Blog
ML Strategies Health Care Preview - Week of February 25th
February 26, 2019|Blog
Device Modernization Series: FDA’s Changes to the 510(k) Program
February 21, 2019|Blog
Mass. House and Senate Leadership Announcements for 2019-2020
February 14, 2019|Article
ML Strategies Health Care Preview - Week of February 11, 2019
February 11, 2019
Save the Date! Mintz Pharmacy & Pharmaceutical Industry Summit on May 2, 2019
February 8, 2019|Blog
ML Strategies Health Care Preview - Week of February 4, 2019
February 4, 2019|Blog
ML Strategies Health Care Preview - Week of January 28, 2019
January 29, 2019|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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