AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020...more
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more
On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical...more
In Tuesday's Report: FDA lists essential medicines and medical countermeasures, Trump plans health official replacement, FDA expands remote monitoring exemption list, WHO director self-quarantines, and other U.S. White House...more
Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration (FDA) announced that it published a list of 223 drug and...more
Tuesday, 20 October 2020 - President Trump’s executive order on essential medicines aims to encourage pharmaceutical companies to bring their manufacturing back to the U.S. But it may also have unintended consequences for...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. ...more
On August 6, President Trump signed an Executive Order, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States, designed to reduce U.S. dependency on foreign sources of...more
On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
President Trump Announces Nomination for Next FDA Commissioner – The president nominated Dr. Stephen Hahn, chief medical executive at the University of Texas MD Anderson Cancer Center, for the position of commissioner of the...more
Food/Dietary Supplements - FDA Issues Report on Certain Dog Foods – The Food and Drug Administration (FDA) continues to investigate cases of dilated cardiomyopathy (DCM) in dogs consuming certain dog foods. ...more
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: Pharma industry CEOs testify before a Senate committee; House and Senate panels probe...more
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: Trump will discuss healthcare and drug costs in this week’s State of the Union address;...more
Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
Food/Dietary Supplements - FDA Issues Added Sugar Guidance – The FDA announced the availability of a guidance document that answers questions about the new food labeling requirements. ...more
A few sound methods can protect you from rising tide of published medical bunk - Medical hype flourishes in the media-saturated modern world, with the internet testing consumer gullibility 24/7. But for a dozen years, an...more
GOP LAWMAKERS: EUROPE, CANADA ‘FREE RIDING’ ON US DRUG INNOVATION - More than two dozen House Republicans last week called on President Donald Trump to leverage upcoming trade negotiations to stop other nations from “free...more
This month, we highlight several significant decisions including The Medicines Company v. Hospira, Inc. and Index Pharmaceuticals, LLC v. Gilead Sciences, Inc. and the Trump administration’s legislative proposal to increase...more
Congressional Republicans and President Donald Trump face a series of key questions about how or whether to fortify the Affordable Care Act – particularly in the law’s beleaguered individual exchanges – after the Senate last...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 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more
During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more