FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
FDA withdraws approval of 34 new drug applications across multiple applicants whose manufacturers requested withdrawal due to discontinued marketing.
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Every rule is broken into specific to-dos with calendar dates.
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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.
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.
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MARAD solicits public comment on a request to operate the foreign-built small passenger vessel S/V KINGSLEY in U.S. coastwise trade carrying no more than twelve passengers for hire.
North Carolina amends the using and controlling agency designations for restricted airspace areas R-5301, R-5302A, R-5302B, and R-5302C without changing boundaries, altitudes, or operational parameters.
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.
FAA proposes to clarify that federal flightcrew and flight attendant duty and rest regulations preempt all state and local meal and rest break requirements under the Airline Deregulation Act of 1978.
The FDA seeks OMB clearance for information collection procedures related to premarket approval of medical devices under the Paperwork Reduction Act.
MARAD is soliciting public comments on a request to operate the foreign-built small passenger vessel S/V GRACIE in U.S. coastwise trade to determine potential adverse effects on domestic vessel builders and coastwise operators.
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