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FDA releases a final guidance entitled Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using...[ Price : $8.95]
FDA reissues a guidance document entitled Process to Request a Review of FDAs Decision Not to Issue Certain Export Certificates fo...[ Price : $8.95]
FDA clears a Neurovalens 510(k) for its Modius Sleep neurostimulation device for treating chronic insomnia.[ Price : $8.95]
Federal Register notice: FDA determines that Novartis Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn ...[ Price : $8.95]
CDRH says it has recognized and supports industrys use of a key consensus standard "ANSI/AAMI SW96:2023 Standard for medical devic...[ Price : $8.95]
Teleflex and subsidiary Arrow International recall their Pressure Injectable Catheter Kits due to mislabeling about the presence o...[ Price : $8.95]
Law firm Sidley petitions FDA on behalf of an unnamed client asking that it not grant orphan-drug exclusivity to Pyros Pharmaceuti...[ Price : $8.95]
Kodiak Sciences says it will conduct another clinical study to support a single BLA for tarcocimab tedromer and its use in three e...