2025 Perspectives in Private Equity: Public Policy
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of Need with Rebecca Thornhill of Maynard Nexsen
Early Returns Law and Politics with Jan Baran: Bradley Smith – Deregulating Political Speech Through Campaign Finance
Legal Risk Management Forum: panel highlights
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications...more
Medical devices race onto the market with little or no effective testing or regulatory safeguards, and a proposed “reform” of the oversight system of products that are implanted in tens of millions of Americans is a sham,...more
The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more
Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more
As a part of the recent speed racing bills through Congress, they have put up HR 1215. Quite erroneously, they have titled it: “Protecting Access to Care Act of 2017”. A read of the act’s text quickly tells any objective...more