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This article notes the pushback the Food & Drug Administration (FDA) and Commissioner Gottlieb are facing after introducing a new plan to overhaul FDA’s clearance process for certain low­ and moderate ­risk medical devices. Mintz Member and Chair of the FDA practice Bethany Hills is among the industry sources quoted providing commentary in the piece.

In an effort to modernize and tighten its medical device clearance process, the Food & Drug Administration (FDA) announced plans to publish the names of devices cleared using predicate devices that are 10 years and older. ML Strategies Senior Director Aaron Josephson, a former FDA Senior Policy Advisor, is among the industry sources quoted in the article providing commentary.
ML Strategies Vice President Rodney Whitlock, a veteran health care policy advisor, is quoted in this article discussing the implications on prescription drug pricing as a result of Senator Chuck Grassley’s return to leading the Finance Committee.

A team of Mintz attorneys - Mike Renaud, Rob Kidwell and Rob Moore - authored this issues response op-ed discussing the Department of Justice's (DOJ) statements on intellectual property rights, "the New Madison Approach." This approach marks a return to the core principles on which the patent laws are predicated.
This Law360 analysis piece looks at how the U.S. Food and Drug Administration (FDA) is easing concerns about off-label marketing restrictions without antagonizing the plaintiffs bar or public health advocates. FDA attorney Joanne Hawana is quoted providing third-party commentary in the piece.
ML Strategies Senior Director Aaron Josephson is among the industry sources providing commentary in this article on the FDA's proposal to test a minimally invasive dog drug study.
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