FDA proposes requiring foreign tobacco product establishment owners and operators to register with the agency and list their products, extending current domestic-only registration requirements to close information gaps.
The FDA seeks OMB approval for information collection procedures related to animal drug applications for minor uses and minor species under the Paperwork Reduction Act.
FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will hold a public meeting to review Capricor's biologics license application for Deramiocel, a cell therapy product, with public comment accepted via docket submission.
FDA classifies medial knee implanted shock absorbers as Class II devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
FDA determines the regulatory review period for VYALEV human drug product patent extension purposes and publishes this notice as required by law.
La Ceiba Foods Latin Market Inc. recalls Requesón Salvadoreño and Requesón Mexicano cottage cheese products under La Colonia and Selectos Latinos brands due to possible Listeria monocytogenes contamination.
Total Nutrition Inc. recalls TNVitamins Organic Moringa capsules and powder due to possible Salmonella exposure in raw ingredient supplied by vendor; no illnesses reported.
FDA revokes Emergency Use Authorizations for three COVID-19 diagnostic devices from Becton Dickinson, InBios International, and Roche Diagnostics upon manufacturer request.
FDA classifies prognostic tests for preeclampsia development or progression as class II devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
FDA classifies computerized behavioral therapy devices for fibromyalgia treatment into class II, requiring special controls to ensure safety and effectiveness while reducing regulatory burdens for manufacturers.
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