FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.
FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equinoxe Reverse Shoulder...
FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.
Senator Ron Johnson (R-WI) launches a congressional investigation into FDAs recent decisions to reject or delay treatments for rare diseases.
FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on one searchable platf...
FDA approves Bristol Myers Squibs Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis.
A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.
FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of study records during ...
