2023 CRA Rule Repeal: Lessons to be Learned
Medicaid Cuts: Potential Challenges and Legal Implications for Long-Term Care Facilities — Assisted Living and the Law Podcast
Predictions regarding the 2023 CRA Rule and Section 1071 and how to prepare for expected developments
Consumer Finance Monitor Podcast Episode: Everything You Want to Know About the CFPB as Things Stand Today, and Lots More - Part 1
2024 Credit Reporting Review: Impactful Changes and Future Forecast — FCRA Focus Podcast
Stumbling Your Way Into a Union: Key Advice for Employers: What’s the Tea in L&E?
Are Overtime Wages and Tips Exempt From Income Tax? What Employers Need to Know to Prepare
The Regulatory Situation After the Trump Executive Orders Regulatory Freeze Pending Review
Consumer Finance Monitor Podcast Episode: The CFPB's Proposed Data Broker Rule
Understanding the DFPI's Proposed Rules: A Deep Dive Into California's Digital Financial Assets Law — The Crypto Exchange Podcast
Understanding the DFPI's Proposed Rules: A Deep Dive Into California's Digital Financial Assets Law — Payments Pros – The Payments Law Podcast
Legal Alert: USPTO Proposes Major Change to Terminal Disclaimer Practice
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
The FTC’s Rule Banning Non-Compete Agreements | What You Need to Know
An In-Depth Analysis of the CFPB’s Proposed Overdraft Rule - The Consumer Finance Podcast
The FTC Takes Initiative to Stop Junk Fees
Long-Term Part-Time Employee Eligibility Rules Now in Effect — Troutman Pepper Podcast
Understanding the CFPB's Proposed Digital Payments Larger Participants Rule and Its Implications for Digital Assets — The Consumer Finance Podcast
Instant Decline, Instant Relief? Unpacking the CFPB's Proposed Rule on NSF Fees — Payments Pros: The Payments Law Podcast
Redefining Banking: A Conversation on the CFPB's Proposed 1033 Rule — Payments Pros: The Payments Law Podcast
Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more
Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more
On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...more
On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more
Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more
Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more
In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more
On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...more
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more
In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products, including radiation-emitting medical devices. ...more