Podcast - New Guidance on Complying with FTC Rule on Deceptive and Unfair Fees
The fatal flaws in the 2023 CRA rule
Consumer Finance Monitor Podcast Episode: The Impact of the Election on the FTC
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
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
FCPA Compliance Report: Death of CTA
2024 Payments Year in Review: CFPB and FTC Regulatory Trends – Part One — Payments Pros – The Payments Law Podcast
Consumer Finance Monitor Podcast Episode: Alan Kaplinsky’s “Fireside Chat” with Former CFPB Leader David Silberman: His Experience During the Prior Transition from the Obama Administration to Trump
SBA’s Final Rule Is Here: Key Takeaways on Updates to HUBZone Program, Other Small Business Programs, and Various Small Business Matters
Hidden Fees in the Live-Event Ticketing and Short-Term Lodging Industries
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Director Review Under the USPTO's Final Rule – Patents: Post-Grant Podcast
#WorkforceWednesday®: After the Block - What’s Next for Employers and Non-Competes? - Spilling Secrets Podcast - Employment Law This Week®
Employment Law Now VIII-150 - The FTC Noncompete Rule is Dead: What Now?
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Sustainable Procurement: A Closer Look at the New Federal Acquisition Regulation (FAR)
Employment Law Now VIII-145 – Status Update: Injunctions for FTC Non-Compete Ban and DOL Overtime Exemption Regs
Legal Alert | Reign It In: Federal Court Enjoins DOL's Expansion of Davis-Bacon Coverage
Consumer Finance Monitor Podcast Episode: What Banking Leaders Need to Know About the U.S. Supreme Court Ruling That the CFPB’s Funding Mechanism is Constitutional Part I
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more
On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment...more
Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more
On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more
Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more
Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more
On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more
On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more
On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more
On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition...more
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
Both chambers of Congress are out of session today and return for the rest of the week. Most healthcare priorities remain out of the congressional spotlight this week, but telehealth is still top of mind. As we...more