FDA issues a draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Appli...
Federal Register notice: FDA issues a final order to reclassify single- use female condoms, renaming the device to single-use internal condom, a posta...
FDA issues two new draft guidance documents one on adaptive clinical trial designs and the other on master protocols that propose important principl...
FDA approves Pfizers Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of certain patients with metastatic non-small cell lung c...
Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) introduce Making Objective Drug Evidence Revisions for New(MODERN) Labeling Act (S 3519) that wo...
FDA clears a de novo request to permit the marketing of Adaptive Biotechnologies ClonoSEQ assay, a next-generation sequencing-based test for minimal r...
FDA releases a final guidance entitled Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic A...
FDA commissioner Scott Gottlieb explains the need for a new Center of Excellence for Digital Health.