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.
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.
FDA draft guidance clarifies Forms FDA 3542a and 3542 submission requirements to assist industry applicants in preparing regulatory filings.
FDA amends regulations to direct the public to its website for organizational and contact information while revoking outdated regulations related to agency structure and contacts.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.
Total Nutrition Inc. expands recall of TNVitamins and Doctor's Pride Ultra Potent Complete Green Superfood Moringa Capsules due to potential Salmonella contamination identified during supply chain review.
Azuma Foods International recalls 545 cases of 3-pack Tako Wasabi seasoned octopus due to undeclared fish allergen that poses serious risk to consumers with fish allergies.
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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.
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