Bureau of Justice Statistics seeks OMB approval to reinstate the Census of Tribal Court Systems information collection with modifications under the Paperwork Reduction Act of 1995.
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.
EPA enforcement agreement resolves Clean Water Act, TSCA, RCRA, and West Virginia pollution violations through proposed consent decree with facility operator.
FDA determines the regulatory review period for VYALEV human drug product patent extension purposes and publishes this notice as required by law.
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 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.
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.
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FDA determines prednisolone tablets 5mg were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory requirements.
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