State AG Pulse | An Early Peek At the 2026 State AG Elections
The Rise of OTAs in Defense Contracting: Opportunities, Risks, and What Contractors Need to Know
Quick Guide to Administrative Hearings
The JustPod: What Do the Lubavitcher Rebbe and the Chabad Chassidic Movement Have to Do With Criminal Justice Reform? It All Starts With “Aleph."
CHPS Podcast Episode 5: The Future of Federal Procurement
Daily Compliance News: June 19, 2025, The Corruption in Spain Edition
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
The VA Primary – A Bellwether For the Country?
DOL Restructures: OFCCP on the Chopping Block as Opinion Letters Expand - #WorkforceWednesday® - Employment Law This Week®
Enforcement Priorities of the Second Trump Administration: The False Claims Act
Project Catalyst: An Economic Development Podcast | Episode 14: Shaping North Carolina’s Economic Future with Secretary of Commerce Lee Lilley
ADA Compliance for Medical and Dental Practices: Responding to Inquiries and Investigations
Work This Way: A Labor & Employment Law Podcast | Episode 45: New Leadership at Employment-Related Federal Agencies with David Dubberly of Maynard Nexsen
What Every Law Firm Leader Can Learn from Law Day and the Perkins Coie Ruling: On Record PR
State AG Pulse | The Inside Scoop: On Being Chief Deputy
Compliance Tip of the Day: Standing at the Turning Point
100 Days In: What Employers Need to Know - Employment Law This Week® - #WorkforceWednesday®
Leadership and Innovation at the Illinois AG's Office — Regulatory Oversight Podcast
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Revolving Door Rules: What You Need to Know Before Hiring from (or Heading to) Government
On August 7, 2025, the Office of the Inspector General (“OIG”) issued Advisory Opinion 25-09 (“Advisory Opinion”) providing a favorable opinion regarding remuneration to physicians with an ownership interest in a medical...more
The Proposed Arrangement - On August 7, 2025, the OIG issued Advisory Opinion 25-09.1 In this instance, the Requestor was a medical device developer, manufacturer, and seller of certain medical devices related to emergency...more
- What is new: DOJ announced a $9.8 million FCA settlement with Illumina Inc. to resolve claims arising out of alleged cybersecurity deficiencies in DNA sequencing systems Illumina sold to government agencies. - Why it...more
Background: The Payback Mechanism and Its Impact - Italy’s payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring...more
In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more
Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more
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
CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more
On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more
Texas House Bill 3749 (HB 3749), known as "Jenifer's Law," has undergone dramatic revisions since its introduction. What began as a bill that could have shuttered many IV hydration clinics has transformed into legislation...more
Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more
In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging...more
The United States Environmental Protection Agency (“EPA”) and Vibracoustic USA, Inc. (“VUI”) entered into an April 21st Consent Agreement (“CA”) addressing alleged violations of the Comprehensive Environmental Response,...more
On this special collaborative episode of Ropes & Gray's Non-binding Guidance and Talkin’ Trade podcast series, life sciences regulatory and compliance partner Josh Oyster is joined by intellectual property litigation partner...more
The U.S. government is pushing to redomesticate the manufacturing of pharmaceutical, biotech, gene therapy, and medical device products, both to bolster U.S. manufacturing generally and to address continuing shortages of...more
Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more
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
On March 17, 2025, the government published a policy paper with an Action Plan for regulation and regulators, outlining how it intends to reform the UK's regulatory system to support growth and innovation. The Action Plan...more
Medical device manufacturers and distributors have come under increasing scrutiny from state licensing agencies and operating without a required license may lead to severe consequences. These can include financial penalties;...more
Key takeaways Faster Negotiations: SCs aim to significantly shorten CTA review times. Scope: The SCs cover specific terms, such as ownership of study results, publication rights, liability limitations, and termination...more
FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more
El Salvador Buys 200 Bitcoins as the Digital Currency Becomes Legal Tender - "El Salvador became the first country to adopt bitcoin as a national currency, kicking off a radical monetary experiment that could pose risks to...more
Our Virtual Regional Compliance Conferences provide updates on the latest news in regulatory requirements, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask questions from...more
Before the onset of the COVID-19 pandemic, companies were already exploring the promise of blockchain to modernize certain aspects of their supply chains. Traditional supply chains can be inefficient, data intensive and...more
On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more