FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Nasal Spray Recalled Due to Yeast Contamination
Ndal Mfg Inc. recalls one lot of Manukaguard Allercleanse after determining the products were contaminated with yeast.
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...
Medical Devices
BrainQ AI for Stroke Gets Breakthrough Status
FDA grants BrainQs artificial intelligence-powered technology for ischemic strokes a breakthrough device designation.
FDA General
Reconciliation Bill Gives FDA $500 Million for Covid Activities
A provision in a budget reconciliation bill moving its way through the U.S. House of Representatives provides FDA with a $500 million boost for Covid-...
