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.
I need the description to create the summary. Please provide the description field for "Combined Notice of Filings #1."
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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FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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.
HUD rescinded its One Stop Customer Service Privacy Act system of records as of October 30, 2024, consolidating functions into its Customer Relationship Management system.
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.
Multiple federal agency forms are undergoing Paperwork Reduction Act review to assess and potentially reduce reporting burdens on small businesses and other respondents.
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.
FCC public notice clarifies records requirements for off-the-record communications with agency staff, affecting broadcasters and telecommunications firms subject to FCC jurisdiction.
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.
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