FDA clears an EliTechGroup 510(k) for its HSV 1&2 ELITe MGB Real-Time PCR assay with the ELITe InGenius sample-to-result instrument.
FDA clears a Stimwave Technologies 510(k) for the WaveCrest Mobile iOS Platform patient controllers for opioid-free pain management.
FDA warns Spains Leventon S.A.U. about Quality System violations in its manufacturing of Dosi Flow infusion pumps and administration sets.
Three medical school professors ask FDA to add warning language about sexual side effects to labeling for all drug products containing isotretinoin.
Federal Register notice: FDA makes available a draft guidance entitled Considerations for the Development of Dried Plasma Products Intended for Transf...
Federal Register notice: FDA withdraws approval of 10 NDAs from multiple applicants after they notified the agency that the drug products were no long...
FDA posts details of an Accreditation Scheme for Conformity Assessment (ASCA) pilot program that aims to enhance the predictability of the medical dev...
An FDA analysis says more ANDAs could be approved in the first cycle if sponsors ensured their applications were complete at the time of filing.