Medical Devices
Hard to Reach Conclusions on Lutonix Catheter: FDA
FDA says it is difficult to draw conclusions on the safety and efficacy of the Lutonix 014 drug-coated balloon PTA catheter.
Biologics
Pfizer sBLA Approved for Panzyga
FDA approves a Pfizer supplemental BLA for Panzyga (immune globulin intravenous [human] ifas 10% liquid preparation) to treat adult patients with chr...
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 2/12/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Final Guide Revised on Convalescent Plasma
FDA issues a revised final guidance entitled Investigational COVID-19 Convalescent Plasma.
Human Drugs
Workshop on Including Older Adults in Trials
FDA announces a 3/23 virtual public workshop entitled Roadmap to 2030 for New Drug Evaluation in Older Adults.
Federal Register
Info Collection Revision on New Drug Applications
Federal Register notice: FDA sends to OMB an information collection revision entitled Application for FDA Approval To Market a New Drug.
Human Drugs
Alnylam Pharma Awarded Priority Review Voucher
Federal Register notice: FDA issues a priority review voucher to Alnylam Pharmaceuticals in response to its rare pediatric disease product application...
Medical Devices
Info Collection on Medical Device Tracking
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices; Device Tracking 21 CFR Part 821 (OMB Control ...
Biologics
Pandemic Delays FDA Action on Mallinckrodt BLA
FDA tells Mallinckrodt that pandemic-related travel restrictions make it necessary to defer action pending a site inspection for its BLA for StrataGra...
