FDA Releases Study Data Technical Conformance Guide Version 2.0, Updates Catalog

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.

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.

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...

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.

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.

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.

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

On October 23, 2026, the U.S. House Committee on Oversight and Government Reform announced an investigation into whether the three largest pharmacy benefit managers (PBMs)—CVS Caremark, Express Scripts and Optum...

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

The Federal Trade Commission has issued warning letters to 24 major healthcare providers, asserting that CMS price transparency rules represent only a regulatory floor and that Section 5 of the FTC Act requires more comprehensive pricing disclosures. Healthcare organizations now face potential enforcement action if their pricing information fails to include complete episode-of-care costs, physician and facility fees, or timely estimates for scheduled services.

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...

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.

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

The New York Stock Exchange and Nasdaq are implementing overnight trading sessions starting December 6, 2026, extending the trading day to nearly 23 hours by compressing the daily pause to just one hour. While this evolution toward continuous trading introduces new considerations for corporate actions, disclosure timing, and deal execution, the practical impact varies significantly between NYSE-listed companies,

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.

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 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

The Ninth Circuit has ruled that health plan participants whose confidential information was disclosed without authorization have standing to sue in federal court, even without showing financial loss or future harm. This decision, which departs from the risk-based approach many courts have applied since TransUnion, relies on the centuries-old action for breach of confidence and could have significant implications for companies' privacy commitments and data-sharing practices.