News & Press Releases

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.

FDA Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are quoted in this article discussing how the FDA’s big-ticket medical device reform initiatives, such as medical software precertification, 510(k) predicate reform and changes to the de novo process likely will continue to develop as planned even as FDA Commissioner Scott Gottlieb, who has drawn attention to such efforts throughout his two-year tenure as agency chief, is due to resign in one month.

FDA Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are quoted in this article discussing the possibility of FDA Principal Deputy Commissioner Amy Abernethy filling in as acting FDA commissioner, or possibly even succeed FDA Commissioner Scott Gottlieb when the current commissioner leaves the agency in a month.

This article previews what may be said of health care in the 2019 State of the Union address. ML Strategies Vice President Rodney Whitlock, a veteran health care policy advisor in Washington, provides commentary in the piece.

Health care industry insiders notes that the actions that Congress decides to take on health care in 2019 will largely be for show. Veteran health care policy advisor Rodney Whitlock, a Vice President with ML Strategies, is among those sources providing commentary in the piece.