[ Price : $8.95]
CDER publishes a MAPP on procedures and responsibilities for Office of New Drug completion and processing of annual status reports...[ Price : $8.95]
FDA warns Chinas Shandong Vianor Biotech about CGMP violations in its production of finished pharmaceuticals.[ Price : $8.95]
CDER medical reviewers say a PTC Therapeutics contested NDA for Translarna does not contain persuasive evidence for the drugs effe...[ Price : $8.95]
FDA worries about medical product shortages as the damage from a hurricane that devastated Puerto Rico is assessed as worse than f...[ Price : $8.95]
CDRH director Jeffrey Shuren and two colleagues say the Center has been using patient-focused data to help in the review of some m...[ Price : $8.95]
Public Citizen faults FDA for issuing a final guidance on changing informed consent requirements without an opportunity for public...[ Price : $8.95]
Federal Register notice: FDA announces an 11/16 public hearing on a potential approach for device sponsors who seek to obtain mark...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Classification of Products as Drugs and Devices & Additiona...