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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FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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.
FAA airworthiness directive requires inspection and repair of missing retaining rings on jettisonable window hinge pins for Airbus Helicopters Model H160-B helicopters.
FDA submitted a proposed information collection to OMB for Paperwork Reduction Act review regarding formal hearing administrative procedures and practices.
Department of Energy approves the Nuclear Fuel Cycle Consortium Voluntary Agreement under the Defense Production Act following public comment and interagency consultation.
North Carolina amends the using and controlling agency designations for restricted airspace areas R-5301, R-5302A, R-5302B, and R-5302C without changing boundaries, altitudes, or operational parameters.
FCC public notice clarifies records requirements for off-the-record communications with agency staff, affecting broadcasters and telecommunications firms subject to FCC jurisdiction.
Public Service Company of Colorado intends to prepare an environmental assessment for proposed utility infrastructure or service modifications subject to regulatory review.
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