Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and developments. A new commissioner has been confirmed (Robert Califf, M.D., who previously...more
Welcome - Welcome to the fourth 2019 issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal...more
When it comes to medical products — devices put in or substances put on our bodies — consumers may be ill-served by the federal regulators who are supposed to protect them from injury....more
Cardiac patients may wish to take to heart how news reports have undercut federal regulators’ claims that they provide the most rigorous oversight to medical devices that treat complex conditions in ways that pose the...more
On March 5, 2019, FDA Commissioner Scott Gottlieb announced his resignation. The physician and venture capitalist, ?for whom this was ?a second stint at the FDA, intends to leave the agency in about a month to spend more time...more
The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in...more
In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more
As many of you know, Scott Gottlieb, M.D. was confirmed by the Senate (57 to 42) on Tuesday, May 9, 2017, to serve as the 23rd Commissioner of the Food and Drug Administration (FDA or agency). Today, he was officially sworn...more
A poet from West London once wrote, "Meet the new boss, same as the old boss," a frustrated statement lamenting that the status quo in any system tends to prevail despite calls for revolution. If one judges the potential for...more