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Federal Register

Comments Extended on Powered Patient Transport

Federal Register notice: FDA extends the comment period for a 6/15 notice on: Exemption from Premarket Notification: Powered Patient Transports.

Federal Register

Patient Advocates Sought for FDA Collaboration

Federal Register notice: FDA and the Clinical Trials Transformation Initiative request applications for patient advocates interested in participating ...

Human Drugs

MAPP on ANDA Labeling Changes

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...

Human Drugs

BMS Pulls Opdivo Indication for Liver Cancer

Bristol Myers Squibb withdraws an indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma who were previously t...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 7/23/2021.

Federal Register

Covid Emergency Use Authorizations Listing Update

Federal Register notice: FDA updates its listing of emergency use authorizations granted during the Covid-19 public health emergency.

Federal Register

Covid-19 Guidance Listing Updated

Federal Register notice: FDA updates its listing of guidance documents related to the Covid-19 public health emergency.

Human Drugs

AbbVies Dalvance Approved for Pediatric Patients

FDA approves AbbVies Dalvance (dalbavancin) for treating acute bacterial skin and skin structure infections in pediatric patients.

Federal Register

Comments Sought on Drug Scheduling

Federal Register notice: FDA seeks comments about abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on ...

Federal Register

Guide on Field Alert Reports

Federal Register notice: FDA makes available a final guidance entitled Field Alert Report Submission: Questions and Answers.