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.
LNC Partners III-SBIC seeks exemption from Small Business Investment Act conflict-of-interest restrictions to permit investments in portfolio companies where fund managers have financial interests.
Economic Injury Disaster Loan declaration for California businesses affected by the Garden Grove Hazmat Incident, effective June 11, 2026.
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.
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.
FDA corrects withdrawal of approval for 11 abbreviated new drug applications; Masuu Global Solutions LLC's propranolol and lidocaine ANDAs remain approved as of March 23, 2026.
Western Mixers Produce & Nuts recalls 9 oz. First Street brand Dark Chocolate Raisins due to undeclared peanuts posing serious risk to allergic consumers.
Illinois Administrative Declaration of a Disaster for the Oak Lawn Apartment Complex Fire issued June 10, 2026, potentially enabling affected small businesses to access state recovery assistance and relief programs.
Rhode Island qualifies for Small Business Administration Economic Injury Disaster Loans following the June 10, 2026 historic snowstorm declaration.
FDA draft guidance clarifies Forms FDA 3542a and 3542 submission requirements to assist industry applicants in preparing regulatory filings.
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