Federal Register
Panel to Vote on Ischemic Stroke System
Federal Register notice: FDA announces a 12/10 meeting of the Medical Devices Advisory Committees Neurological Devices Panel that will review a Brains...
Human Drugs
Biocon Malaysian Plant Gets 6-item FDA-483
FDA posts a six-observation Form FDA-483 after inspecting a Biocon drug substance manufacturing facility in Malaysia.
Medical Devices
FDA Information Page on Endometrial Ablation
CDRH creates a patient resource Web page to provide information about endometrial ablation for heavy menstrual bleeding.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 10/22/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 10/22/2021.
Federal Register
Guide on Submitting Real-world Data
Federal Register notice: FDA makes available a draft guidance entitled Data Standards for Drug and Biological Product Submissions Containing Real-Worl...
Federal Register
20 Drugs Not Withdrawn Over Safety/Efficacy
Federal Register notice: FDA determines that 20 listed drug products were not withdrawn from sale due to safety or effectiveness issues.
Human Drugs
Hold on Tryp Therapeutics Eating Disorder Study
FDA issues a clinical hold against Tryp Therapeutics and a Phase 2a study evaluating its psilocybin for eating disorders.
Biologics
PD-1 Inhibitor BLA Yanked After Keytruda Approval
Agenus withdraws a BLA for balstilimab after FDA urged it to do so following Mercks recent full approval for pembrolizumab for treating cervical cance...
