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.
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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FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
The Office of the Assistant Secretary for Health seeks public comments on a proposed threshold for scheduling 7-hydroxymitragynine under the Controlled Substances Act.
FDA withdraws approval of 34 new drug applications across multiple applicants whose manufacturers requested withdrawal due to discontinued marketing.
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.
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.
Multiple federal agency forms are undergoing Paperwork Reduction Act review to assess and potentially reduce reporting burdens on small businesses and other respondents.
EPA announces receipt of pesticide residue petitions for various commodities and opens public comment period; petitions filed in 2025 and 2026 are under evaluation for regulatory establishment or modification.
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