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FDA issues a draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Dru...[ Price : $8.95]
Federal Register notice: FDA issues a final order to reclassify single- use female condoms, renaming the device to single-use inte...[ Price : $8.95]
FDA issues two new draft guidance documents one on adaptive clinical trial designs and the other on master protocols that propos...[ Price : $8.95]
FDA approves Pfizers Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of certain patients with metastatic n...[ Price : $8.95]
Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) introduce Making Objective Drug Evidence Revisions for New(MODERN) Labeling ...[ Price : $8.95]
FDA clears a de novo request to permit the marketing of Adaptive Biotechnologies ClonoSEQ assay, a next-generation sequencing-base...[ Price : $8.95]
FDA releases a final guidance entitled Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, ...[ Price : $8.95]
FDA asks pen needle manufacturers to add a label Warning regarding proper use of the devices.