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 seeks OMB approval for information collection requirements regarding establishment, maintenance, and availability of traceability records for certain foods under the Paperwork Reduction Act.
FDA submits proposed information collection procedures for safe processing and importing of fish and fishery products to OMB for Paperwork Reduction Act review.
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.
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 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 combined acoustic and electrical external stimulation devices for tinnitus relief as Class II medical devices, subject to special controls to ensure safety and effectiveness.
Ascension Health Alliance consent order settles Federal Trade Commission allegations of unfair competitive practices in healthcare operations.
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.
Clover Hill Dairy voluntarily recalls all Soft Ricotta/Requeson Cheese products due to potential Listeria monocytogenes contamination posing health risks to vulnerable populations.
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