FDA grants MolecuLight de novo classification allowing marketing of its wound fluorescence imaging device, the MolecuLight i:X.
Researchers say more recalls occur with foot and ankle medical devices cleared through 510(k)s than approved through PMAs.
Federal Register notice: FDA withdraws the approval of 20 ANDAs from multiple applicants.
Federal Register notice: FDA submits to OMB a new information collection request entitled Experimental Study of Risk Information Amount and Location i...
FDA warns Paramesh Banerji Life Sciences about CGMP violations in its production of finished pharmaceuticals.
Oncology Center of Excellence director Richard Pazdur solicits stakeholder comments on a new draft guidance on cancer trials using multiple expansion ...
Attorney Jeffrey Gibbs outlines provisions advanced by FDA as a new approach to regulating in vitro diagnostics and laboratory-developed tests.
FDA warns Chinas Yicheng Goto Pharmaceuticals about significant deviations of current good manufacturing practice regulations for active pharmaceutica...