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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.
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.