United States: Food, Drugs, Healthcare, Life Sciences

The FDA has released new draft guidance establishing a comprehensive risk-based framework for evaluating container closure systems used in pharmaceutical packaging, marking a significant update from its 1999 guidance. This framework addresses five critical factors including material safety, environmental protection, performance standards, manufacturing impacts, and storage considerations, with particular emphasis on leachables assessment and quality control programs across different drug delivery routes.

On June 8, 2026, four central agencies jointly published a revamped Good Clinical Practice (GCP) standard, effective Sept. 1, 2026. It is materially shorter than the standard it replaces, and that compression is the point: China’s GCP now incorporates International Council for Harmonisation (ICH) E6(R3) by reference rather than restating it, and it reallocates responsibility among sponsors, service providers, investigators, and sites in ways that may require contract amendments before the effective date.

On May 15, 2026, a substantial revision of China’s Implementing Regulations of the Drug Administration Law (the Regulations or Implementing Regulations) took effect, introducing, among other items, a formal data protection framework. On the same day, China’s National Medical Products Administration (NMPA) issued the Implementing Measures for Drug Trial Data Protection (the Measures), giving operational effect to the Regulations’ data-protection article for the first time since China accepted the underlying obligation upon World Trade Organization (WTO) accession.

The Federal Circuit vacated a PTAB decision on patent obviousness, establishing that a provisional application must provide written description support for at least one published claim to qualify as prior art under its earlier filing date. This ruling clarifies the requirements for claiming priority from provisional applications and impacts how patent practitioners should approach provisional filing strategies.

Biocon Limited has commercially launched YESAFILI (aflibercept-jbvf), a biosimilar to Regeneron's EYLEA, in the United States following settlement agreements that lifted previous injunction barriers. This marks the second aflibercept biosimilar available in the U.S. market, entering a competitive landscape where patent litigation continues to shape biosimilar entry strategies. The launch follows a complex legal journey involving multiple jurisdictions and settlement negotiations that ultimately permitted ea

The Centers for Medicare and Medicaid Services has issued a final rule prohibiting federal Medicaid and CHIP funding for gender-affirming care for minors, effective October 2026. This comprehensive analysis examines the rule's scope, legal framework, state-by-state implications, and operational impacts on healthcare providers, insurers, and families navigating coverage restrictions.

State legislatures are rapidly expanding oversight of health care transactions, with eight states enacting new laws targeting private equity involvement, MSO arrangements, and REIT transactions. These regulations introduce complex notice requirements, approval processes, and corporate practice restrictions that fundamentally alter how health care deals must be structured and timed.

The Department of Homeland Security’s new rule eliminating “duration of status” for F, J and I nonimmigrants will have significant implications for healthcare organizations that sponsor and train international physicians.

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.