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.
EPA enforcement agreement resolves Clean Water Act, TSCA, RCRA, and West Virginia pollution violations through proposed consent decree with facility operator.
FAA supersedes prior airworthiness directives for Airbus Helicopters Models AS332C, AS332C1, AS332L, and AS332L1 by requiring modification of cabin lateral sliding plug door release or jettison systems to terminate repetitive inspections.
FAA airworthiness directive mandates repetitive inspections and corrective actions for fastener holes in Airbus A321-251NX through A321-272NX center fuselage frame foot joints due to manufacturing process deviations.
FAA airworthiness directive requires Airbus Helicopters AS350 series operators to inspect cargo hook gaps and replace affected units or prohibits their installation to address safety non-conformities.
FAA requests OMB approval to renew its information collection for aircraft operators applying for privacy ICAO addresses through a web-based system to ensure airworthiness monitoring and enforcement compliance.
FAA proposes airworthiness directive for Airbus Helicopters Deutschland Model EC135 and EC635 helicopters requiring repetitive tail rotor blade inspections for cracks caused by intergranular corrosion and removal of affected assemblies.
FAA proposes airworthiness directive for Airbus A330 aircraft requiring modification or repetitive inspections of anti-ice piccolo tube restraint brackets to address cracking and breakage hazards.
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.
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