Human Drugs
FDA Seeks Quality Process Change in Toripalimab BLA
FDA issues a complete response letter to Shanghai Junshi Biosciences and Coherus BioSciences on their BLA for toripalimab in combination with gemcitab...
Human Drugs
IND Safety Reports eSubmission Guide
FDA posts a final guidance entitled Electronic Submission of IND Safety Reports Technical Conformance Guide.
Medical Devices
CDRH Unveils Organizational Changes, New Offices
CDRH announces organizational changes that include new offices established within the Office of Product Evaluation and Quality.
Human Drugs
FDA Hold on Vertex Cell Therapy for Diabetes
FDA places a clinical hold on a Vertex Pharmaceuticals Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated ...
Medical Devices
Bakul Patel Leaving CDRH After 13 Years
After 13 years at the agency, CDRH Digital Health Center of Excellence director Bakul Patel announces he will be leaving the agency early this month t...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 4/29/2022.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 4/29/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Crohns Disease Draft Guidance Released
FDA posts a draft guidance entitled Crohns Disease: Developing Drugs for Treatment that discusses clinical trial considerations.
Federal Register
Gilead Sciences Gets Priority Voucher for Veklury
Federal Register notice: FDA issues a priority review voucher to Gilead Sciences under the agencys material threat medical countermeasure program.
