FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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.
New York's Administrative Declaration of Disaster dated June 30, 2026, covers severe storms and flooding and may trigger state and federal disaster assistance programs for affected small businesses.
MARAD solicits public comments on a request to permit the foreign-built vessel S/V LADY SUSAN to operate in U.S. coastwise trade carrying no more than 12 passengers for hire, to determine potential adverse effects on domestic vessel builders and coa…
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.
FAA airworthiness directive requires Airbus Helicopters Model H160-B operators to modify affected windows in jettisoning systems and prohibits installation of non-conforming windows or doors on helicopters with Supplemental Type Certificate SR00223I…
HUD rescinded its One Stop Customer Service Privacy Act system of records as of October 30, 2024, consolidating functions into its Customer Relationship Management system.
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 vessel M/V DEUCE in U.S. coastwise trade carrying no more than twelve passengers for hire, to assess potential impacts on U.S. vessel builders and coastwise trade operator…
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