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 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.
Department of Labor seeks public comment on proposed extension of Medical Travel Refund Request forms (OWCP-957A for mileage, OWCP-957B for expenses) under the Paperwork Reduction Act.
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.
The Department of Labor is extending approval of its information collection for requests to approve conformed wage classifications and unconventional fringe benefit plans under the Davis-Bacon and Related Acts; public comments are invited.
FDA draft guidance clarifies Forms FDA 3542a and 3542 submission requirements to assist industry applicants in preparing regulatory filings.
FDA amends regulations to direct the public to its website for organizational and contact information while revoking outdated regulations related to agency structure and contacts.
Nara Organics recalls all lots of powdered infant formula nationwide due to potential Clostridium botulinum contamination posing risk of infant botulism.
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