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FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
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FDA withdraws approval of 34 new drug applications across multiple applicants whose manufacturers requested withdrawal due to discontinued marketing.
I need the description to create an accurate summary. Please provide the description field for this OMB submission document.
CDC seeks public comment through [date] on the Expanding PrEP in Communities of Color (EPICC) data collection effort, which supports shared decision-making training and evaluation for preexposure prophylaxis providers serving diverse populations.
CDC seeks public comment on a proposed Management Information System for Comprehensive Cancer Control Programs that will conduct annual key informant interviews and biennial surveys to monitor program outcomes.
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.
The FDA seeks OMB clearance for information collection procedures related to premarket approval of medical devices under the Paperwork Reduction Act.
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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