National Institutes of Health seeks 30-day public comments on proposed information collection forms for the Genetic Testing Registry before submitting to Office of Management and Budget for approval.
FDA classifies monitors for opioid-induced impairment of oxygenation as class II medical devices, subject to special controls to ensure safety and effectiveness.
The Centers for Medicare & Medicaid Services re-establishes a matching program with the Peace Corps to verify eligibility for minimum essential coverage under the Affordable Care Act through Peace Corps health benefit plans.
National Institutes of Health Director's Office holds a public meeting to discuss agency policies and operations affecting biomedical research funding and grant administration.
FDA classifies skin patches for hyperhidrosis treatment as Class II medical devices, requiring special controls to ensure safety and effectiveness while expediting patient access to the technology.
Center for Scientific Review closed meeting on May 22, 2025 to discuss peer review procedures and personnel matters related to grant applications and program administration.
FDA determines the regulatory review period for VYALEV human drug product patent extension purposes and publishes this notice as required by law.
FDA classifies medial knee implanted shock absorbers as Class II devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will hold a public meeting to review Capricor's biologics license application for Deramiocel, a cell therapy product, with public comment accepted via docket submission.
FDA proposes requiring foreign tobacco product establishment owners and operators to register with the agency and list their products, extending current domestic-only registration requirements to close information gaps.
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