FDA classifies ingestible gastrointestinal blood detection capsules as class II devices, establishing special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
FDA classifies radiological machine learning-based quantitative imaging software with predetermined change control plans as Class II medical devices, subject to special controls to ensure safety and effectiveness.
The FDA issues a final 5-year debarment order against Andrew Jonathan Morgan, prohibiting him from importing or offering for import any drug into the United States based on a federal felony conviction related to drug importation.
SEC Regulation 14A requires public companies to file proxy statements and related materials with standardized disclosure forms and deadlines for shareholder meetings.
SEC Regulation 14C requires proxy disclosures and shareholder communications for certain corporate actions; OMB review period open for public comment on information collection requirements.
The Agency for Healthcare Research and Quality seeks OMB approval to extend the AHRQ Research Reporting System information collection with reduced annual burden and expanded scope to include grants, contracts, and challenge competitions.
Cboe BZX Exchange amends its fee schedule to remove a note from the Member Quoting Tier and MPID Quoting Tier, effective immediately upon filing.
NYSE Arca amends Rule 7.35-E to modify trading halt procedures and notification requirements for listed securities on its exchange platform.
24X National Exchange LLC amends member transaction rebate structures; rule change effective immediately upon filing.
NYSE Arca proposes amending Rule 8.201-E to modify generic listing standards for commodity-based trust shares, extending the SEC's review period for this rule change.
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