The FDA plans to allow drug approvals based on a single clinical trial instead of the traditional two. Commissioner Marty Makary stated that this change aims to streamline the approval process while maintaining safety and efficacy standards. Some exceptions will still apply, where two trials may be required.

• FDA will now generally accept a single clinical trial for drug approval instead of the traditional two
• Two trials will still be required in certain (unspecified) cases
• Makary argues a well-designed, controlled single trial can match the statistical power of two trials
• Many drugmakers were already submitting only one pivotal trial, so the policy formalizes existing practice

Hospital-at-home care is facing significant challenges in managing medical waste, as existing disposal regulations do not fully apply to at-home settings. Healthcare professionals report difficulties with proper waste management, which raises safety concerns for patients and caregivers. As the model continues to grow, there is a pressing need for proactive regulation and effective waste disposal solutions.

• 373 hospitals were approved for hospital-at-home programs as of January 2023, showing rapid growth of a model with no matching waste rules.
• A 2023 report found managing pharmaceutical and medical waste was healthcare workers' top concern in home care, with most wanting more resources to handle it.
• Patients themselves are often left responsible for disposing of hazardous items like sharps and pharmaceuticals, since hospital-grade disposal regulations don't apply at home.
• A 2024 CMS study found at-home care much cheaper than hospital care, fueling calls for investment in a "reverse supply chain" to safely collect and process medical waste from homes.