FDA withdraws approval of 34 new drug applications across multiple applicants whose manufacturers requested withdrawal due to discontinued marketing.
The FDA seeks OMB clearance for information collection procedures related to premarket approval of medical devices under the Paperwork Reduction Act.
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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.
The Office of the Assistant Secretary for Health seeks public comments on a proposed threshold for scheduling 7-hydroxymitragynine under the Controlled Substances Act.
Department of the Treasury Bureau of Fiscal Service seeks public comment on the Certificate of Identity information collection under the Paperwork Reduction Act of 1995.
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.
OFAC has added persons to the Specially Designated Nationals and Blocked Persons List, blocking all U.S.-jurisdiction property and prohibiting U.S. persons from transacting with them.
FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
Treasury Department seeks public comment on the TreasuryDirect System information collection under the Paperwork Reduction Act of 1995 to assess respondent burden and paperwork requirements.
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.
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