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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
Arizona 1115 Medicaid Waiver Update
January 22, 2019|Blog
ML Strategies Health Care Preview - Week of January 22nd
January 22, 2019|Blog
News & Press Releases
Former Senate Staffer Reveals How Congress Can Pass an Autonomous Vehicle Bill
November 19, 2019 | Legaltech News
In this Q&A published by Legaltech News, Vice President of ML Strategies Christian Fjeld—former lead Democratic Senate staffer tasked with shepherding the American Vision for Safer Transportation through Advancement of Revolutionary Technologies Act (AV START Act) through the Senate—discussed why Congress failed to pass the AV START Act, how autonomous vehicles’ complexity isn’t lawmakers’ largest hurdle, and why the data privacy debate may factor into the next autonomous vehicle bill.
Warren, Cassidy To FDA: How Will You Identify Device Remanufacturers?
October 23, 2019 | Inside Health Policy
An article published by Inside Health Policy quoted Aaron Josephson, Senior Director at ML Strategies, on Senators Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) letter to U.S. Food and Drug Administration (FDA), requesting information about the FDA's upcoming guidance clarifying the distinction between remanufacturers and servicers.
To Pitch Pre-Cert to Congress, FDA Builds a Case First
September 26, 2019 | MedTechDive
MedTechDive reported that the U.S. Food and Drug Administration is not yet ready to go to Congress to seek new powers for its evolving precertification pilot for software, but it will need new authorities to determine how the experimental path fits into the current regulatory scheme. The article included commentary from Senior Director of ML Strategies Aaron Josephson and Mintz Associate Benjamin Zegarelli.
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2019