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FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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.
The Maritime Administration invites public comments on a determination request for the foreign-built M/V MEAT WAGON 2 to operate in U.S. coastwise trade carrying up to twelve passengers for hire.
Department of Energy approves the Nuclear Fuel Cycle Consortium Voluntary Agreement under the Defense Production Act following public comment and interagency consultation.
MARAD solicits public comments on a request to permit the foreign-built vessel S/V LADY SUSAN to operate in U.S. coastwise trade carrying no more than 12 passengers for hire, to determine potential adverse effects on domestic vessel builders and coa…
MARAD solicits public comment on a request to operate the foreign-built small passenger vessel S/V KINGSLEY in U.S. coastwise trade carrying no more than twelve passengers for hire.
FCC public notice clarifies records requirements for off-the-record communications with agency staff, affecting broadcasters and telecommunications firms subject to FCC jurisdiction.
FDA submitted a proposed information collection to OMB for Paperwork Reduction Act review regarding formal hearing administrative procedures and practices.
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