FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.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.
Tell Bizmoon what your business does and we'll cut the Federal Register down to what actually matters.
Every rule is broken into specific to-dos with calendar dates.
We tell you which parts of your business each rule actually touches.
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.
HUD rescinded its One Stop Customer Service Privacy Act system of records as of October 30, 2024, consolidating functions into its Customer Relationship Management system.
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…
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 small passenger vessel S/V GRACIE in U.S. coastwise trade to determine potential adverse effects on domestic vessel builders and coastwise operators.
The Maritime Administration invites public comments on a determination request for the foreign-built M/V MEAT WAGON 2 to operate in U.S. coastwise trade carrying up to twelve passengers for hire.
The FDA seeks OMB clearance for information collection procedures related to premarket approval of medical devices under the Paperwork Reduction Act.
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.
No legal jargon. Read the impact in two sentences.
Email + dashboard pings the moment something changes.
