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FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
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Every rule is broken into specific to-dos with calendar dates.
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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 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.
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.
Federal agencies submit information collection requests to OMB for review and public comment to assess burden on businesses and the public.
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.
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.
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