Coast Guard establishes a temporary regulated navigation area on the Hudson River near Albany, NY prohibiting unauthorized vessel entry and imposing slow-no-wake speed restrictions during construction of the Livingston Avenue Railroad Swing Bridge.
FDA seeks 60 days of public comment on information collection requirements for Biologics License Applications under the Paperwork Reduction Act; deadline for comments is 60 days from Federal Register publication.
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After healthcare come the capital-heavy sectors: trade, transportation, energy, and finance. If you operate in one of them, the volume of change is relentless.
FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
Coast Guard establishes temporary safety zone in Monroe Harbor and Lake Michigan near Chicago to prohibit unauthorized vessel and personnel access during fireworks and drone show operations.
Coast Guard enforces a safety zone during the Super Boat Grand Prix in Michigan City, Indiana from August 1–2, 2026, prohibiting unauthorized entry, transit, or anchoring in the regulated area.
The FCC prohibits importation and marketing of communications equipment designated as covered products in 2024 or earlier due to national security risks.
FDA corrects contact information for the Expedited Investigational New Drug Pilot Program docket, which solicits public input on shortening timelines from drug identification to first-in-human clinical trials.
The FDA seeks OMB clearance for information collection procedures related to premarket approval of medical devices under the Paperwork Reduction Act.
FDA withdraws approval of 34 new drug applications across multiple applicants whose manufacturers requested withdrawal due to discontinued marketing.
FDA submitted a proposed information collection to OMB for Paperwork Reduction Act review regarding formal hearing administrative procedures and practices.
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