FDA Review posts Federal Register notices for the week ending 11/25/2016.
Federal Register Notice: FDA determines the regulatory review period for Bristol Myers Squibbs lung cancer therapy Opdivo (nivolumab) for patent exten...
Federal Register Notice: FDA determines the regulatory review period for Novo Nordisks diabetes therapy Tresiba (insulin degludec injection) for paten...
FDAs Center for Veterinary Medicine (CVM) issues a revised compliance policy guide, effective immediately, on the extralabel use of medicated feed for...
A federal jury in Dallas returns a combined verdict of more than $1 billion on behalf of six people who suffered serious medical complications caused ...
FDA approves a new indication for Eli Lillys Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with Type 2 diabet...
FDA steps up its focus on combination products and plans to finalize its guidance on human factors and GMPs this coming year.
FDA releases a guidance on the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products Content and Format that ...