Becton Dickinsons CareFusion unit recalls its Alaris Patient Controlled Analgesia infusion pump module 8120 because the compatible syringes labeling c...
A Lassman Law petition filed for an unidentified client asks FDA not to approve an Amryt NDA for Filsuvez to treat cutaneous manifestations of junctio...
Federal Register notice: FDA makes available a guidance entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Lis...
Former FDA reviewer Sarah McGarry joins consulting firm Greenleaf Health as senior vice president of drug and biological products.
The CDER Office of Prescription Drug Promotion says two Otsuka Rexulti ads contain misleading presentations of the drugs efficacy.
FDA releases the form FDA-483 with 14 observations from an inspection at the Kilitch Healthcare India sterile drug manufacturing facility in Maharasht...
Federal Register notice: FDA proposes to withdraw approval of Phibro Animal Healths NADAs for carbadox in medicated swine feed.
The International Society for Cell & Gene Therapy suggests ways to improve an FDA draft guidance on manufacturing changes and comparability for human ...
