Roche announces FDA approval of label expansion into biliary tract cancer
Roche (RHHBY) announced the FDA approval of a label expansion into biliary tract cancer, or BTC, for the Pathway anti-HER2/neu Rabbit ...
Medscape4 天
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.
Cure Today5 天
The FDA Approves Labeling Update for Sandoz in the Treatment of B-Cell CLL
The FDA has approved updated drug labeling for Sandoz in the treatment of B-cell chronic lymphocytic leukemia.
Animal Welfare Institute4 年
OIG Audits USDA Label Approval Process
The report, Controls Over Meat, Poultry, and Egg Product Labels, investigated the label approval program of the Food Safety and Inspection Service (FSIS). In the audit, the OIG found that 9 of 60 ...