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FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
FDA withdraws approval of 34 new drug applications across multiple applicants whose manufacturers requested withdrawal due to discontinued marketing.
The FCC prohibits importation and marketing of communications equipment designated as covered products in 2024 or earlier due to national security risks.
Department of Energy approves the Nuclear Fuel Cycle Consortium Voluntary Agreement under the Defense Production Act following public comment and interagency consultation.
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…
FAA proposes to clarify that federal flightcrew and flight attendant duty and rest regulations preempt all state and local meal and rest break requirements under the Airline Deregulation Act of 1978.
FCC public notice clarifies records requirements for off-the-record communications with agency staff, affecting broadcasters and telecommunications firms subject to FCC jurisdiction.
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.
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