The FDA is proposing to reclassify nucleic acid-based diagnostic test systems designed for use with oncology drugs, which may affect regulatory requirements and market availability.
Plain language summary generated by AI · Civitics
Filing of Color Additive Petition: International Association of Color Manufacturers; Request to Amend the Color Additive Regulations to Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride
Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests