FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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.
Tell Bizmoon what your business does and we'll cut the Federal Register down to what actually matters.
Every rule is broken into specific to-dos with calendar dates.
We tell you which parts of your business each rule actually touches.
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.
Centers for Medicare & Medicaid Services launches a matching program with the Department of Veterans Affairs to verify eligibility for insurance affordability programs under the Affordable Care Act.
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…
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 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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