FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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.
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…
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.
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.
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…
MARAD is soliciting public comments on a request to operate the foreign-built small passenger vessel S/V GRACIE in U.S. coastwise trade to determine potential adverse effects on domestic vessel builders and coastwise operators.
The FDA seeks OMB clearance for information collection procedures related to premarket approval of medical devices under the Paperwork Reduction Act.
NIH requests 60-day public comment on proposed data collection for citizen science and crowdsourcing projects under Paperwork Reduction Act review; deadline is 60 days from publication.
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