Workplace Violence in Health Care: Dissecting the Legal Landscape and Implications for Employers – Diagnosing Health Care
TortsCenter Podcast | Episode 5 | Higher Standards or Higher Stakes
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
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
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
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
In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” urging drug manufacturers to...more
The U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an additional six months, citing the challenges...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. ...more
On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more
On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives...more
During a year in which legislative activity was restrained by a variety of factors, most notably the Senate’s inability to maintain a consistent majority, the New York State Legislature nonetheless still passed 641 bills,...more