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.
Proposed Final Judgment in US antitrust case against Live Nation Entertainment requires the company to divest certain assets and comply with operational restrictions affecting ticket sales and venue management; final judgment pending court approval.
FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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 submitted a proposed information collection to OMB for Paperwork Reduction Act review regarding formal hearing administrative procedures and practices.
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.
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.
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…
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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