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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Rothwell, Figg, Ernst & Manbeck, P.C.

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

Rothwell, Figg, Ernst & Manbeck, P.C. on

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more

Paul Hastings LLP

White House Releases AI Action Plan: "Winning the Race: America's AI Action Plan"

Paul Hastings LLP on

On July 23, the White House released its strategic action plan on AI, “Winning the Race: America’s AI Action Plan” (the AI Action Plan), which is designed to secure U.S. global leadership in AI with a strategic focus on...more

BakerHostetler

Analysis of the 2025 Federal Tax Changes Under the “One Big Beautiful Bill” Legislation

BakerHostetler on

The race to remake portions of the Internal Revenue Code (Code) and to prevent expiration of certain Tax Cuts and Jobs Act (TCJA) provisions reached completion with Legislation signed by President Trump on July 4, 2025....more

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

Troutman Pepper Locke on

Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Latham & Watkins LLP

FDA and NIH Announce Initiatives to Reduce Animal Testing and Encourage Alternative Methodologies

Latham & Watkins LLP on

The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more

Health Care Compliance Association (HCCA)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

Health Care Compliance Association (HCCA) on

When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Mass layoffs of federal workers impact NIST and AI Safety Institute, Google unveils AI “co-scientist” system,...

McDonnell Boehnen Hulbert & Berghoff LLP on

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

Skadden, Arps, Slate, Meagher & Flom LLP

Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts

Skadden, Arps, Slate, Meagher & Flom LLP on

Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more

Mintz - Antitrust Viewpoints

Trump Taps David Sacks as AI and Crypto Czar — AI: The Washington Report

Mintz - Antitrust Viewpoints on

On December 5, incoming President Donald Trump announced that David Sacks would be the “AI and Crypto Czar” under the next administration. A prominent venture capitalist, member of the “PayPal Mafia,” and co-founder of an...more

Akin Gump Strauss Hauer & Feld LLP

Calling-in from COP29: What You Missed and What Comes Next

Akin Gump Strauss Hauer & Feld LLP on

World leaders, scientists, government decision-makers, private sector actors, climate actionists and other stakeholders have convened at 29th Conference of the Parties (COP29) to the United Nations Framework Convention on...more

Mintz - Health Care Viewpoints

OHRP Workshop Highlights Artificial Intelligence Uses, Concerns in Human Research

Mintz - Health Care Viewpoints on

The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice”...more

Walkers

Global Legal Insights FinTech 2024: Ireland chapter

Walkers on

The Irish government has been supportive of the development of the financial services sector in Ireland and this extends to fintech. The government’s strategy for the development of Ireland’s international financial services...more

Health Care Compliance Association (HCCA)

‘No Evidence’: Judges Toss KU Researcher’s Conviction; Reinstatement Battle Is Next

Health Care Compliance Association (HCCA) on

“I am writing with good news!!! Yesterday, the 10th Circuit overturned Franklin’s only remaining conviction and ordered the trial judge to enter a verdict of NOT GUILTY!!! After five long and difficult years, Franklin has...more

Mintz - Energy & Sustainability Viewpoints

Energy & Sustainability Washington Update – August 2024

Mintz - Energy & Sustainability Viewpoints on

New Bipartisan Energy Permitting Reform Legislation - US Senators Joe Manchin (I-WV) and John Barrasso (R-WY), Chairman and Ranking Member of the Senate Energy and Natural Resources Committee, have unveiled the Energy...more

Holland & Knight LLP

New Requirements for Research Security Programs Raise the Stakes for Compliance

Holland & Knight LLP on

The National Security Presidential Memorandum-33 (NSPM-33), issued in January 2021, directed federal agencies that fund research and development (R&D) projects to require certain "Covered Institutions" to certify that the...more

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

Health Care Compliance Association (HCCA) on

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

Latham & Watkins LLP

Healthcare and Life Sciences Trends and Developments Across MENA

Latham & Watkins LLP on

The healthcare and life sciences ecosystem is witnessing significant growth in the Middle East as the GCC continues to seek economic diversification. The United Arab Emirates (UAE) and Kingdom of Saudi Arabia (KSA) are...more

Davies Ward Phillips & Vineberg LLP

Federal Budget 2024: How It Impacts You and Your Business

Davies Ward Phillips & Vineberg LLP on

On April 16, 2024 (Budget Day) the Honourable Chrystia Freeland, Deputy Prime Minister of Canada and Minister of Finance, delivered the Liberal Party’s federal budget (Budget 2024). Budget 2024 included a number of proposed...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Skadden, Arps, Slate, Meagher & Flom LLP on

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Gardner Law

FDA's View on Cannabis

Gardner Law on

The U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first draft guidance on clinical trials involving...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

Health Care Compliance Association (HCCA) on

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Health Care Compliance Association (HCCA)

Moffitt Center’s FCA Settlement is First of 2024; Questions Surround Nature of Billing Errors

Health Care Compliance Association (HCCA) on

Moffitt Cancer Center’s recent $19.5 million settlement with the U.S. Department of Justice (DOJ) and the state of Florida resolving allegations that billing errors violated the False Claims Act (FCA) triggered a “fully...more

Mintz - ML Strategies

ML Strategies Outlook for 2024

Mintz - ML Strategies on

Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

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

McDonnell Boehnen Hulbert & Berghoff LLP

International Trade Commission Issues Report of COVID-19 IP Waiver

McDonnell Boehnen Hulbert & Berghoff LLP on

It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more

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