FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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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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.
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.
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.
Coast Guard establishes a temporary safety zone on the Potomac River near Fairview Beach, Virginia for a fireworks display on July 11, 2026, prohibiting unauthorized vessels and persons from entering without Captain of the Port approval.
The FAA proposes to supersede Airworthiness Directive 2009-04-13 for Rolls-Royce Deutschland BR700 series engines, requiring operators to revise engine maintenance programs to incorporate manufacturer-issued time limits for life-limited parts.
FDA submitted a proposed information collection to OMB for Paperwork Reduction Act review regarding formal hearing administrative procedures and practices.
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.
The FDA seeks OMB clearance for information collection procedures related to premarket approval of medical devices under the Paperwork Reduction Act.
US Coast Guard establishes temporary safety zones for the Ocean City, NJ "Night in Venice" Fireworks Display in the East District to regulate vessel traffic during the marine event.
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