FDA says the Magellan Diagnostics recall of its LeadCare and LeadCare II blood lead testing systems is Class 1.
Two CDER staffers present the Centers expectations for data integrity and CGMPs at a quality assurance meeting.
Former FDA associate chief counsel for enforcement Peter Leininger joins King & Spalding.
FDA clears a Clarify Medical 510(k) for the Clarify Medical Phototherapy System, a light therapy device for treating diseases such as psoriasis, vitil...
Bristol-Myers Squibb and Qiagen enter into an agreement to explore using next-generation sequencing technology to develop gene expression profiles as ...
FDA approves a Roche PMA supplement for the cobas CMV (cytomegalovirus) test for use on its automated cobas 6800 and cobas 8800 Systems.
CEL-SCI Corp. responds to FDA about a clinical hold placed on the companys Phase 3 head and neck cancer study with Multikine (leukocyte interleukin in...
FDA allows the de novo marketing clearance of Claret Medicals Sentinel Cerebral Protection System to protect against the risk of stroke by capturing a...