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.
FDA seeks OMB approval for information collection requirements regarding establishment, maintenance, and availability of traceability records for certain foods under the Paperwork Reduction Act.
FDA classifies simple point-of-care SARS-CoV-2 detection devices as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
FDA classifies Spinal Muscular Atrophy newborn screening test systems as Class II devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
FDA submits proposed information collection procedures for safe processing and importing of fish and fishery products to OMB for Paperwork Reduction Act 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.
FDA extends the comment period for its drug repurposing request for information to allow stakeholders additional time to submit input on addressing unmet medical needs.
FDA reopens the comment period for its industry guidance on scale-up and postapproval changes for drug dosage forms to allow additional stakeholder input.
FDA amends sunscreen monograph M020 to add bemotrizinol at concentrations up to 6 percent as a generally recognized as safe and effective active ingredient for over-the-counter sunscreen products.
FDA classifies combined acoustic and electrical external stimulation devices for tinnitus relief as Class II medical devices, subject to special controls to ensure safety and effectiveness.
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