Workplace Violence in Health Care: Dissecting the Legal Landscape and Implications for Employers – Diagnosing Health Care
Cannabis Law Now Podcast: Cannabis Companies and the Corporate Transparency Act
Third-Party Risk Management in Bank-Fintech Partnerships: Strategies and Insights — Payments Pros – The Payments Law Podcast
Compliance Unveiled: 10 Must-Know Tips for the Pregnant Workers Fairness Act & Independent Contractor Rules
Examining FinCEN FAQs, Proposed Legislation and Other CTA Developments
Webinar: Corporate Transparency Act
Year in Review: Key Regulatory Updates in 2023
DE Under 3: Potential Elimination of EEO-1 Type 4 & 8 Reports
Consumer Finance Monitor Podcast Episode: Perspectives on Counseling on the Creation of Consumer Finance Products, with Guest Joseph Schuster, Managing Director and Senior Counsel, Goldman Sachs
Webinar Recording - Artificial Intelligence An Overview of the U.S. and EU Regulatory Landscape
On-Demand Webinar | Regulatory Uncertainty and Linear Infrastructure Projects: Where Are We and What’s Ahead?
Welcome to Regulatory Matters
Abdul Rahman Al Jaabari on a Virtual Reality Code of Ethics & Business Conduct
Pamela Para on Effective Investigations in Healthcare
M&A in the Cannabis Sector
On-Demand Webinar | Linear Infrastructure Redux: Adapting Your Projects to Meet the New Regulatory Climate
Wiley Webinar: Biotech Briefings – U.S. Department of Agriculture – Plant Pests and Importation Part 330
Healthcare Tech: What Legal Pitfalls Should Tech Companies Avoid As They Jump Into Healthcare?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - FDA Regulated Natural Products: Leveraging IP and Regulatory Requirements to Maximize Possible Return on Investment
Blakes Continuity Podcast: Cutting Through the Weeds: A Look at Environmental Issues Impacting Businesses
On August 9, 2024, China’s State Administration for Market Regulation (SAMR) released a draft of the Anti-Monopoly Guidelines for the Pharmaceutical Sector (hereinafter referred to as the “AMGP”) for public comment. The AMGP...more
The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more
On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more
The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more
After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
Contaminated eye drops present serious risks. Not only can they cause blindness and other serious medical conditions, but they have also been linked to at least four cases of premature death caused by severe bacterial...more
On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations...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
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more
Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more
On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more
From the end of the COVID-19 public health emergency (PHE) to the overturning of Roe v. Wade to the growth of AI in health care, multiple forces are converging to remap the health care landscape. In a new webinar, Manatt...more
In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more
Powerful ideas emerge when you look at something through a completely different lens. And when two parties come together to share those unique perspectives? That’s when the magic happens. Womble Bond Dickinson’s virtual...more
YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more
Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
Hear from a global team on the crucial legal and regulatory topics investors need to know when buying or investing in Clinical Trial Site Management Organizations. Investing in pharma services is complicated, but our team...more
The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more
In 1973, Sir Elton John sang, “Harmony and me, we’re pretty good company,” on his classic album, Goodbye Yellow Brick Road. More than 50 years later, the Food and Drug Administration issued a Final Rule to amend the medical...more
On February 2, 2024, the “gang of six”—a bipartisan group of six senators who have traditionally championed reforms to the 340B program1 —introduced a discussion draft of a bill that would modify the program that provides...more