FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
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.
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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.
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.
The FDA seeks OMB clearance for information collection procedures related to premarket approval of medical devices under the Paperwork Reduction Act.
FDA withdraws approval of 34 new drug applications across multiple applicants whose manufacturers requested withdrawal due to discontinued marketing.
Centers for Medicare & Medicaid Services launches a matching program with the Department of Veterans Affairs to verify eligibility for insurance affordability programs under the Affordable Care Act.
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FCC public notice clarifies records requirements for off-the-record communications with agency staff, affecting broadcasters and telecommunications firms subject to FCC jurisdiction.
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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…
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