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FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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.
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.
FAA airworthiness directive requires inspection and repair of missing retaining rings on jettisonable window hinge pins for Airbus Helicopters Model H160-B helicopters.
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.
Department of Energy approves the Nuclear Fuel Cycle Consortium Voluntary Agreement under the Defense Production Act following public comment and interagency consultation.
FCC public notice clarifies records requirements for off-the-record communications with agency staff, affecting broadcasters and telecommunications firms subject to FCC jurisdiction.
Dominion Energy South Carolina's application to amend its turbine venting plan is accepted for filing with a comment period open for public intervention and protests.
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