FDA Issues Technical Specifications Document For Quality Metric Data

The FDA has escalated enforcement against online peptide sellers through warning letters and criminal prosecution, while state medical boards impose stricter standards on prescribers. Recent actions reveal how research-use-only disclaimers fail when evidence shows intended human use, and one case resulted in a 70-month prison sentence combined with $5 million forfeiture.

The U.S. Food and Drug Administration has released a discussion paper outlining its initial framework for regulating generative AI-enabled medical devices, proposing a two-axis risk assessment approach and a novel competency-based premarket evaluation system. With public comments due by October 19, 2026, this represents a critical opportunity for device manufacturers and stakeholders to shape the regulatory landscape for this transformative technology.

The Trump administration's most-favored-nation pricing initiative has expanded to include nine additional mid-sized pharmaceutical manufacturers, bringing the total coverage to 89% of the brand drug market. These new agreements focus on Medicaid pricing discounts aligned with international rates, while manufacturers commit billions to U.S. manufacturing and research in exchange for exemptions from future pricing mandates and potential tariffs.

Over the past year, industry has had a front row seat as the Food and Drug Administration (“FDA” or the “Agency”) decides just how much leeway it wants to afford the manufacture, marketing, and sale of peptide products, and just where it wants to draw the line. Despite the recent decision of FDA’s Pharmacy Compounding Advisory Committee (“PCAC”) to recommend a number of peptides for inclusion on the 503A bulks list process — a move that represents a potentially more permissive stance toward peptide regulation, at least in terms of what can and cannot be compounded under 503A...

In Snyder v. Virginia Mason Medical Center, No. 104136-5 (Wash. Oct. 1, 2026), the Washington Supreme Court held that corporate defense counsel, risk managers, and claims adjusters may not communicate ex parte with a hospital’s former employee health care providers about patient care. The Court reaffirmed Loudon v. Mhyre, 110 Wn.2d 675, 756 P.2d 138 (1988) prohibiting ex parte communication by defense counsel with a plaintiff’s treating physicians, held that prejudice is presumed when Loudon is violated, and ruled that a quality improvement (QI) committee member’s involvement in defense strategy waives the committee’s statutory privilege under Wash. Rev. Code § 70.41.200.

As previously reported, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) recently voted in favor of adding six peptides—BPC-157, KPV, TB-500...

On Friday, California Office of Health Care Affordability (“OHCA”) published proposed final regulations that implement a 2026 law that significantly expanded OHCA’s review authority over health care transactions involving private equity (“PE”) groups, hedge funds, and management services organizations (“MSOs”). Stakeholders involved in California health care transactions should re-assess whether their ongoing or contemplated transactions are implicated by these regulations, because newly covered transactions will need to comply with the 90-day advance notice requirement established in the original OHCA regulations.

In October 2025, California Governor Gavin Newsom signed Assembly Bill 1503 into law, marking a significant change for pharmacies located outside California...

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

The FDA, in collaboration with federal partners, held a landmark public hearing on September 14, 2026, to gather input on the future therapeutic use of psychedelic drugs, drawing over 18,000 registered attendees. This hearing represents one of the earliest implementations of Executive Order 14401, which directs federal agencies to expedite research, review, and approval of psychedelic drugs for serious mental health conditions.

The Code is voluntary, but it will likely become an important reference point for demonstrating compliance with Article 50 of the AI Act.

The Ninth Circuit Court of Appeals vacated a preliminary injunction against Perplexity AI, determining that when an AI agent acts at a user's direction, it is the user—not the AI company—who "accesses" computer systems under federal and California computer fraud statutes. This landmark appellate decision addresses how existing computer-access laws apply to agentic artificial intelligence and has significant implications...

The European Commission has initiated infringement procedures against 20 EU Member States for failing to transpose the EmpCo Directive by the March 27, 2026 deadline. This directive aims to combat greenwashing by requiring substantiation of environmental claims and third-party certification for sustainability labels, with full implementation expected by September 27, 2026.

Mexico's comprehensive anti-money laundering framework has undergone a sweeping transformation through Acuerdo 115/2026, introducing mandatory risk-based methodologies, enhanced client due diligence protocols, and automated monitoring requirements. With implementation deadlines beginning March 1, 2027, obligated parties conducting vulnerable activities face compressed timelines to overhaul their compliance infrastructure while navigating heightened enforcement risks and stricter beneficial ownership thresho

China's Supreme People's Court has issued comprehensive judicial rules addressing artificial intelligence disputes, establishing frameworks for product liability, intellectual property rights, and data protection. These landmark opinions provide critical guidance for global companies navigating AI-related legal risks in China's evolving regulatory landscape.

A federal court has struck down New York's Climate Change Superfund Act, which sought to recover $75 billion from fossil fuel companies based on historical emissions. The ruling found the Act preempted by the Clean Air Act, marking the first judicial decision on state climate superfund legislation and establishing that EPA's rescission of the endangerment finding does not alter preemption analysis.

The European Commission has proposed replacing the EU's three core procurement directives with a single, directly applicable Regulation that would fundamentally reshape how companies compete for public contracts across Member States. The reform introduces mandatory quality criteria thresholds, embeds ESG considerations as evaluation factors, and establishes new security and European-preference provisions that could restrict participation based on ownership, supply chain exposure, and strategic dependencies.

The European Commission has adopted final Guidelines on exclusionary abuses of dominance under Article 102 TFEU, introducing a "workable effects approach" that narrows presumptions while expanding guidance on objective justifications and recognizing sustainability benefits as valid efficiencies for the first time. These Guidelines replace the 2008 Enforcement Priorities Guidance and are expected to significantly impact enforcement practices across EU Member States and beyond, particularly for digital market

France's Anti-Corruption Agency has imposed its first-ever monetary sanctions under the Sapin II Act, penalizing a company €350,000 and its president €60,000 for widespread compliance failures. The landmark decision establishes critical precedents for enforcement strategy, breach assessment timing, and personal executive liability in anti-corruption matters.

The user of defective goods benefi ts from several causes of action against the vendor or manufacturer.