Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
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
Following years of heightened concern about the dangers of exposure to ethylene oxide (EtO), increased regulatory oversight, and a steady hum of litigation, in 2025 it seems like things might be changing for the beleaguered...more
This proclamation addresses the EPA’s April 5, 2024 final rule, National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review, 89...more
ADA Advocating for Fluoridation, Says Medical Devices Should Not Be Subjected to Tariffs - The dental industry and DSOs are experiencing change as both continue to embrace technology, including AI. The political and...more
Welcome to your monthly rundown of all things administrative law, where we highlight all the happenings you may have missed. ...more
Regulation and litigation surrounding per- and polyfluoroalkyl substances (PFAS) – a class of organic chemicals used in a variety of industrial and consumer products – is on the rise and evolving day-by-day. And the PFAS...more
On January 14, 2025, the Biden administration’s U.S. Environmental Protection Agency (EPA) posted a last-minute “interim” decision in the Federal Register for its review of ethylene oxide (EtO) under the Federal Insecticide,...more
The U.S. Environmental Protection Agency (EPA) announced on December 5, 2024, that it published updates to its Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing (Recommendations). EPA notes...more
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
On September 13, 2024, the U.S. Environmental Protection Agency (EPA) began a public comment period on a proposed update to its Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing...more
The US Environmental Protection Agency (EPA) recently announced that it is expanding its Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing Program (Recommendations Program) to include new...more
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
On April 16, 2024, Maine Governor Janet Mills signed into law significant amendments to the PFAS in Products Law. Initially passed in 2021, the PFAS in Products Law required manufacturers of products with intentionally added...more
Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S. history to...more
Over the past seven years, our blog has reported extensively on PFAS developments, litigation, and regulations — most of which has focused on the attention surrounding potential risks associated with PFAS, and the scrutiny...more
A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more
Following the U.S. Environmental Protection Agency’s 2016 finding that ethylene oxide (EtO), a highly effective chemical routinely used to sterilize medical devices and equipment, was significantly more hazardous than...more
With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused...more
Following a study of 100 commercial sterilizer facilities, the U.S. Environmental Protection Agency announced on August 3 it would takes steps to inform communities throughout the country about the risks posed by ethylene...more
In this month’s update, state high courts consider reimbursement of defense costs, reimbursement of medical marijuana costs, and reimbursement of ransomware payments. Federal courts determine whether a debt collector is...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
The rapid spread of the coronavirus has generated new interest in the regulation of medical waste. The COVID-19 crisis is generating a significant amount of regulated medical waste....more
The Federal Communications Commission (FCC) regulates wireless medical devices in conjunction with the Food and Drug Administration (FDA), with the FCC’s role related to certain technical concerns such as the successful...more
As the Trump presidency completes its first 10 weeks, the administration is celebrating big wins on the regulatory reform front while nursing some wounds from a major defeat on efforts to repeal and replace the Affordable...more
With the last-minute passage of a Continuing Resolution (CR) to stave off a government shutdown, the 114th Congress has come to an end. When Congress returns in January, it will be faced with a number of immediate challenges,...more
On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, "The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic...more