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
FDA Withdraws Approval for 216 ANDAs
Federal Register notice: FDA withdraws the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit required annual report...
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Federal Register notice: FDA makes available a draft guidance entitled Data Standards for Drug and Biological Product Submissions Containing Real-Worl...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20 Drugs Not Withdrawn Over Safety/Efficacy
Federal Register notice: FDA determines that 20 listed drug products were not withdrawn from sale due to safety or effectiveness issues.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...
FDA Approves Large Photodynamic Therapy Light
FDA approves Biofronteras BF-RhodoLED XL, a red-light source for photodynamic therapy and its combination use with the companys Ameluz gel for treatin...
Human Drugs
Susvimo Eye Implant for Wet AMD Approved
FDA approves Genentechs Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for treating certain people with wet, or neo...
