FDA revises a Manual of Policies and Procedures (MAPP) entitled Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, an...
Bristol Myers Squibb withdraws an indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma who were previously t...
FDA Review posts the Federal Register notices for the week ending 7/23/2021.
Federal Register notice: FDA updates its listing of emergency use authorizations granted during the Covid-19 public health emergency.
Federal Register notice: FDA updates its listing of guidance documents related to the Covid-19 public health emergency.
FDA approves AbbVies Dalvance (dalbavancin) for treating acute bacterial skin and skin structure infections in pediatric patients.
Federal Register notice: FDA seeks comments about abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on ...
Federal Register notice: FDA makes available a final guidance entitled Field Alert Report Submission: Questions and Answers.