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FDA clears an EliTechGroup 510(k) for its HSV 1&2 ELITe MGB Real-Time PCR assay with the ELITe InGenius sample-to-result instrumen...[ Price : $8.95]
FDA clears a Stimwave Technologies 510(k) for the WaveCrest Mobile iOS Platform patient controllers for opioid-free pain managemen...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Considerations for the Development of Dried Plasma Products...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of 10 NDAs from multiple applicants after they notified the agency that the drug p...[ Price : $8.95]
FDA posts details of an Accreditation Scheme for Conformity Assessment (ASCA) pilot program that aims to enhance the predictabilit...[ Price : $8.95]
An FDA analysis says more ANDAs could be approved in the first cycle if sponsors ensured their applications were complete at the t...[ Price : $8.95]
FDA medical reviewers raise questions about several aspects of an Alkermes NDA for a combination drug to treat major depressive di...[ Price : $8.95]
FDA commissioner Scott Gottlieb introduces a new Plant and Animal Biotechnology Innovation Action Plan to help ensure the safety o...