[ Price : $8.95]
CDRH consumer safety officer Vidya Gopal uses a Webcast to describe requirements in the production and process controls subsystem.[ Price : $8.95]
A Science investigative report details the large percentage of clinical trials that fail to meet legal requirements for submitting...[ Price : $8.95]
FDA warns Health Pharma about CGMP violations in its work as a contract manufacturer of finished drugs.[ Price : $8.95]
Ultragenyx Pharmaceutical and Kyowa Kirin file a supplemental BLA for Crysvita (burosumab) for treating FGF23-related hypophosphat...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Health Pharma, Huaian Zongheng Bio-Tech and James W. Findling.[ Price : $8.95]
FDA warns Chinas Huaian Zongheng Bio-Tech about CGMP violations in its work as a contract producer of finished drugs.[ Price : $8.95]
Vifor asks FDA to restrict the approval pathway for harder-to-copy complex drugs such as its products treating iron deficiency.[ Price : $8.95]
FDA denies a petition asking it not to approve an NDA for Neurelis Valtoco, and approves the NDA.