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
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
DE Under 3: FAR Council Submitted for OMB Approval Proposed Rule on “Pay Equity and Transparency in Federal Contracting”
The FTC Announces Three Important Developments
Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...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
Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more
On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...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
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
The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more
The Centers for Medicare & Medicaid Services (CMS) has pushed back its plan for issuing a final rule updating the Physician Self-Referral law (the "Stark Law") by one year to August 31, 2021. Ostensibly the rule, when...more
Nearly a decade after the Affordable Care Act signaled a transition of the U.S. health care system to value-based care, the Department of Health and Human Services (HHS) published on October 9 two long-awaited proposed rules...more