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.
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.
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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 withdraws approval of 34 new drug applications across multiple applicants whose manufacturers requested withdrawal due to discontinued marketing.
FDA submitted a proposed information collection to OMB for Paperwork Reduction Act review regarding formal hearing administrative procedures and practices.
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 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FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
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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