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 July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more
On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more
Four U.S. senators reported their findings of a nine-month investigation into direct-to-consumer telehealth platforms used by pharmaceutical manufacturers, highlighting risks and reinforcing the need for industry to carefully...more
On June 19, 2025, Canada’s Drug Agency (“CDA”) opened a public consultation to gather input on a proposed list of essential prescription drugs and related products. This initiative is part of the agency’s responsibilities...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
The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more
On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more
We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more
From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...more
On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Measures for the Protection of Drug Trial Data (the “Draft Measures”), along with its accompanying implementation guidelines, the...more
On May 5, President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines,” with the stated purpose of eliminating “regulatory barriers to the domestic production...more
On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more
FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....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
As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more
Last week, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced an impending reduction in force (RIF) of approximately 10,000 positions, including about 3,500 Food and Drug Administration (FDA)...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
On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...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
As we previously reported, on December 19, 2024, the Patented Medicine Prices Review Board (PMPRB) released its Draft Guidelines for PMPRB Staff regarding Administrative Process for Excessive Price Hearing Recommendation...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...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