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 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
On January 10, 2024, Senators Chris Coons and Thom Tillis introduced a bill titled Improving Efficiency to Increase Competition Act (“IEICA”). The IEICA would require that the Comptroller General provide a report to certain...more
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...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
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
On 11 June 2020, the Court of Justice of the European Union (CJEU) delivered a judgement in case C-786/18 GmbH v. Novartis Consumer Health GmbH. The judgment followed a request for a preliminary ruling by the German Federal...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
Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more
The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and...more
In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more
The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more
The Situation: On May 28 and 29, 2018, the European Commission ("Commission") published two studies aimed at examining the economic and legal impacts of the European Union's regime on Supplementary Protection Certificates...more
On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more