Work This Way: A Labor & Employment Law Podcast | Compliance Clarity for Federal Contractors with Joan Moore and Mim Munzel of Arbor Consulting Group
Great Women in Compliance: LATAM Compliance Update with Alejandra Montenegro Almonte
Podcast - Regulating AI in Healthcare: The Road Ahead
Mid-Year Labor & Employment Law Update: Key Developments and Compliance Strategies
Sunday Book Review: July 13, 2025, The Best Books on History Edition
Compliance into the Weeds: Changes in FCPA Enforcement
Amend (Don’t End) DEI: What SHRM’s BEAM Framework Means for Law Firms - On Record PR
Navigating Renewable Energy: Insights from the ACP Siting and Permitting Conference - Energy Law Insights
New Executive Order Targets Disparate Impact Claims Nationwide - #WorkforceWednesday® - Employment Law This Week®
2024-2025 Bid Protest Decisions with Far-Reaching Impacts for Government Contractors
Consumer Finance Monitor Podcast Episode: The Impact of the Election on the FTC
What Every Law Firm Leader Can Learn from Law Day and the Perkins Coie Ruling: On Record PR
The Changing Landscape of EEOC Enforcement and Disparate Impact
Compliance Tip of the Day: Standing at the Turning Point
ESG Essentials: What You Need To Know Now - Episode 19 - Power Struggles: Federal vs. State Authority in Energy Law
Episode 366 -- DOJ Issues Data Security Program Requirements
Non-Competes Eased, Anti-DEI Rule Blocked, Contractor Rule in Limbo - Employment Law This Week® - #WorkforceWednesday®
CHPS Podcast Episode 3: Unlocking America's Mineral Potential
CHPS Podcast Episode 2: Bitcoin in the Halls of Power
On March 14, 2025, President Trump signed Executive Order (EO) 14236, rescinding 19 executive actions, including former President Biden’s September 2022 EO 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a...more
On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...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
AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more
On October 30, 2023, the Biden Administration released and signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order) that articulates White House...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
On February 24, the USPTO extended the written comment period for Joint USPTO–FDA Collaboration Initiatives until March 10, 2023....more
On January 19, 2023, the U.S. Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) held a “listening session” focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's...more
On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: ...more
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more
The USPTO will be hosting a “public listening session” on January 19, 2023, focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's Executive Order on “Promoting Competition in the American...more
On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in...more
On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order...more
President Biden has revealed the next areas of focus in his effort to protect the United States’ technological leadership and economic competitiveness: biotechnology, biomanufacturing, and the bioeconomy....more
On September 12, 2022, President Biden issued an Executive Order (EO) calling on his Administration to renew efforts to improve the clarity and efficiency of regulatory processes for biotechnology products. Launching a new...more
President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or...more
On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more