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FDA clears an MRI Interventions 510(k) for its latest software platform, ClearPoint 2.0.[ Price : $8.95]
Attorney Scott Lassman says protein drug sponsors may sue FDA over a 2016 draft guidance on requiring BLAs for such products as of...[ Price : $8.95]
FDA releases the latest FDA-483 detailing problems at another Akorn manufacturing facility, this time in Somerset, NJ.[ Price : $8.95]
The Association for Accessible Medicines calls for changes to the proposed U.S.-Mexico-Canada Free Trade Agreement to better prote...[ Price : $8.95]
FDAer Abena Agyemanm says the agency has published a table of surrogate endpoints that were used or could be used to indicate effi...[ Price : $8.95]
FDA approves Ortho Clinical Diagnostics Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Orthos V...[ Price : $8.95]
FDA releases a guidance on Hypertension: Developing Fixed-Combination Drug Products for Treatment.