FDA commissioner Scott Gottlieb pledges during a congressional hearing to revamp the new drug development process for targeted drugs.
FDA clears a ConforMIS 510(k) for the iTotal Hip replacement system.
FDA clears a Medicrea Group 510(k) for UNiD HUB, a data-driven digital portal for the companys Adaptive Spine Intelligence.
Seattle Genetics says it is discontinuing its Phase 3 CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leu...
FDA issues a draft guidance on ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.
Federal Register notice: FDA proposes a new drug advertising study entitled Experimental Study of Risk Information Amount and Location in Direct-to-Co...
Federal Register notice. FDA seeks comments on an information collection extension for requirements for accepting Electronic Records; Electronic Signa...
Federal Register notice. FDA seeks comments on an information collection extension for EMA/FDA application form for orphan drug designation.