Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 2/18/2022.
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 2/18/2022.
Federal Register
More Product-specific Guidances for ANDAs
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide recommendations on ANDA bioequ...
Federal Register
Info Collection Extension on CDRH Appeals Processes
Federal Register notice: FDA seeks comments on an information collection extension entitled Center for Devices and Radiological Health Appeals Process...
Federal Register
Electromechanical Tear Stimulator in Class 2
Federal Register notice: FDA classifies the electromechanical tear stimulator into medical device Class 2.
Federal Register
Integrated Continuous Glucose Monitor is Class 2
Federal Register notice: FDA classifies the integrated continuous glucose monitoring system into medical device Class 2.
Federal Register
Class 2 for Percutaneous Catheter for Hemodialysis
Federal Register notice: FDA classifies the percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access into medical device...
Human Drugs
BioMarin Hold Extended as FDA Seeks More Data
FDA extends a clinical hold on BioMarin Pharmaceuticals PHEARLESS Phase 1/2 study of BMN 307, an AAV5-human phenylalanine hydroxylase gene therapy bei...
FDA General
Put Priority on Data/Technology and Staff: FDA Alliance
The Alliance for a Stronger FDA says that commissioner Robert Califfs first priorities should focus on renewed attention to data and technology modern...
