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."
FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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.
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.
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.
MARAD is soliciting public comments on a request to operate the foreign-built vessel M/V DEUCE in U.S. coastwise trade carrying no more than twelve passengers for hire, to assess potential impacts on U.S. vessel builders and coastwise trade operator…
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