Podcast - Regulating AI in Healthcare: The Road Ahead
Wild Times for the Community Reinvestment Act
Mid-Year Labor & Employment Law Update: Key Developments and Compliance Strategies
Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Point-of-Sale Finance Series: Unpacking Leases and RTO Models — The Consumer Finance Podcast
Suluki Secrets: Behind the Scenes of Reasonable Investigations — FCRA Focus Podcast
Understanding BBB Ratings: Building Trust and Mitigating Risks — Regulatory Oversight Podcast
Regulatory Rollback: Legal Challenges and Opportunities in Earned-Wage Access — Payments Pros – The Payments Law Podcast
Regulatory Rollback: Legal Challenges and Opportunities in Earned-Wage Access — The Consumer Finance Podcast
LathamTECH in Focus: Tech Deals: The Emerging Focus of FDI Regulators?
LathamTECH in Focus: Navigating National Security: The Impact of FDI Reviews on Tech M&A
Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
Daily Compliance News: July 22, 2025, The I-9 Hell Edition
Compliance Tip of the Day: Avoiding CCO Liability
Compliance Tip of the Day: COSO Governance Framework - Part 5, People
SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
Balch’s Consumer Finance Compass: How Standing Can Make or Break Certification for Class Action Lawsuits in Debt Collection
Top challenges with Compliance Management
Innovation in Compliance: Allison Lagosh on Proactive Compliance Planning for Regulatory Changes
Daily Compliance News: July 15, 2025, The Fighting Workplace Bullying Edition
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more
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
The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more
Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more
M&A in the AI sector is redefining deal risk, especially when sensitive data is involved. As AI companies power breakthroughs in biotech, healthcare, defense, and critical infrastructure, the stakes for companies acquiring...more
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
The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs and biological products “with more effective,...more
The biotech mergers and acquisitions market faces significant headwinds in the first half of 2025. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug Administration (FDA) and...more
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...more
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more
On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more
With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment often leads to mergers and acquisitions (M&A) as a vehicle for larger companies to...more
On January 15, 2025, BIS issued an Interim Final Rule that amends the Export Administration Regulation (EAR) to address dual use export control concerns about biotechnology. ...more
The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more
More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...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
In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9,...more
On October 1, 2019, in In re Clovis Oncology, Inc. Derivative Litigation, a Delaware Chancery Court denied a motion to dismiss the plaintiffs’ claims under the Caremark decision against individual directors for failing to...more
On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more
On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law...more
On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more