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.
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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FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
The Drug Enforcement Administration announces temporary scheduling of mitragynine pseudoindoxyl, MGM-15, and MGM-16 as Schedule I controlled substances, restricting manufacturing, distribution, possession, and research activities.
DEA issues temporary scheduling order placing 7-hydroxymitragynine above a specified threshold in Schedule I, subjecting manufacturers, distributors, importers, exporters, and researchers to Schedule I controlled substance regulations and penalties.
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.
FCC public notice clarifies records requirements for off-the-record communications with agency staff, affecting broadcasters and telecommunications firms subject to FCC jurisdiction.
Federal Communications Commission invites public comment on information collection requirements under the Paperwork Reduction Act, with specific focus on reducing burdens for small businesses with fewer than 25 employees.
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