Podcast - Rewriting the Narrative of Private Equity in Healthcare
SBA’s Final Rule Is Here: Key Takeaways on Updates to HUBZone Program, Other Small Business Programs, and Various Small Business Matters
Workplace Violence in Health Care: Dissecting the Legal Landscape and Implications for Employers – Diagnosing Health Care
Keeping up with all the new regulations
PODCAST: Williams Mullen's Gavels & Gowns - What’s Next in VA Higher Education? An Interview Featuring Chris Peace, President of CICV
Podcast - The FTC's Regulation of Social Media Advertising
Clocking in with PilieroMazza: PilieroMazza Launches Labor & Employment Podcast for GovCons
State AG Pulse | Wrangling Acronyms: SAGs, ORC and AI
NCAA President Charlie Baker’s NIL Comments – Highway to NIL
Consumer Finance Monitor Podcast Episode: Recent Federal and State Debt Collection Developments
JONES DAY TALKS®: The Rise of AI Regs: Approaches from the European Union and United States
Hinshaw Insurance Law TV – The Future of ESG
Webinar Recording – 2023 Preview for Privacy and Data Security
On-Demand Webinar | California Employment Law Update: Tips for Staying Compliant in 2023
Hot Topics in International Trade with Braumiller Law Group: Customs Broker Modernization Regulations 19 CFR 111
The Justice Insiders Podcast: Mutiny on the Bug Bounty
Stoel Rives | Deeply Rooted Podcast S2E3: The Intersection Between Alcohol and Agriculture with Jess Thomas, co-founder of SOGOOD Saké
New Regulation: Statutes, Pillars, and the Build Back Better Act
Podcast: Interoperability - the Role of Health Information Exchanges - Diagnosing Health Care
2BInformed: Engaging with EPA, OSHA’s New Regulation, and Asbestos
President Donald Trump recently signed an Executive Order (EO) aimed at lowering the cost of prescription drugs, titled, “Lowering Drug Prices by Once Again Putting Americans First.” On April 15, 2025, through this EO, the...more
The U.S. Food and Drug Administration (FDA) on April 10, 2025, announced a significant policy shift aimed at reducing its reliance on animal testing for drug development and incorporating new approach methodologies (NAMs)...more
On January 10, 2025, China's State Administration for Market Regulation ("SAMR"), the top anti-graft regulator, put into effect its first-of-its-kind Compliance Guidelines for Healthcare Companies to Prevent Commercial...more
In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more
The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...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
Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more
On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more
On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more
On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...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 November 27, 2024, the New York State Department of Financial Services (DFS) will be releasing new regulations governing pharmacy benefit managers (PBMs). Beginning with legislation in 2021, New York has been active in...more
As mentioned last week, the Centers for Medicare & Medicaid Services (CMS) recently put out a large buffet of regs – too many to digest in one blog post. While we focused on the Calendar Year (CY) 2025 Physician Fee Schedule...more
On October 10, 2024, Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received Royal Assent. This legislation establishes a framework for a national universal pharmacare system, aiming to enhance the...more
On October 10, 2024, the Council of the European Union adopted the new EU Directive on Liability for Defective Products (New PLD), repealing Directive 85/374/EEC (PLD), adopted in 1985....more
The UK government has recently announced that it plans to introduce a Cyber Security and Resilience Bill (Bill). The Bill seeks to update the 2018 Network and Information Security Regulations, which implemented the European...more
To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for...more
On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S. history to...more
In February 2024, the U.S. Food and Drug Administration (FDA) published its finalized guidance concerning its investigational drug charging regulations (found at 21 C.F.R. § 312.8). These regulations are applicable to...more
This is the sixth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more