News & Press Releases

A July 8 article published by The Boston Globe reported that the New England Aquarium is aiming to become a bold advocate on environmental matters, in conjunction with its plans for significant expansion.

Mintz Member and Chair of the Energy & Sustainability practice Tom Burton, Chair-Elect of the New England Aquarium Board of Trustees, recently led the search committee for the aquarium’s chief executive, Vikki Spruill, a longtime advocate for marine conservation. “Board members believe the nonprofit needs to forcefully advocate for conservation measures, and educate the public about what they can do,” Mr. Burton said.

The article also noted that ML Strategies is registered to represent the aquarium with respect to waterfront development on and around Central Wharf.

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.”

Nancy Sterling, Senior Vice President, Strategic Communications at ML Strategies, shares her insights around crisis communication in this Q&A with PRSA Boston Buzz.

ML Strategies Senior Director Aaron Josephson is featured in this article, which discusses a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress – that could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.

This article explores American Clinical Laboratory Association (ACLA) president and CEO Julie Khani’s desire to start a dialogue with FDA to refine aspects of a draft bill that would redefine the agency’s regulatory authority over diagnostics. Specifically, she hopes to work with the agency on revisions to the bill's provision involving precertification and modification of existing tests in order to make those concepts less burdensome for test makers. Aaron Josephson, a senior director at ML Strategies and former senior policy advisor at FDA’s device center, is among the industry sources quoted within the piece.