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TXT FDA Wants to Change Generic Drug Exclusivity: Attorney [2928 Words] [ Price : $8.95]
Attorney Kurt Karst says an FDA proposal to change the way generic drug exclusivity is awarded will result in fewer generic drugs coming to market.
03/31/2022
 
 
TXT PQ/CMC Information Electronic Submission Project [2669 Words] [ Price : $8.95]
FDA describes progress to date on its project to identify and prioritize pharmaceutical quality/chemistry, manufacturing, and controls (PQ/CMC) information that would benefit from a structured submission approach.
03/31/2022
 
 
TXT FDA OKís Edwards Mitral Heart Valve [196 Words] [ Price : $8.95]
FDA approves Edwards Lifesciencesí Mitris Resilia valve, a tissue valve replacement specifically designed for the heartís mitral position.
03/31/2022
 
 
TXT Magellan Resumes LeadCare II Distribution [2615 Words] [ Price : $8.95]
FDA says Magellan Diagnostics is again distributing its LeadCare II blood test that had been part of a 2021 recall for a significant risk of falsely low results.
03/31/2022
 
 
TXT FDA Updates Covid Vaccine EUA Guidance [2702 Words] [ Price : $8.95]
FDA updates its guidance on materials to be submitted to support the issuance of an emergency use authorization for a Covid-19 vaccine.
03/31/2022
 
 
TXT Inspections Prioritized to Find Compliance/Data Integrity Issues [645 Words] [ Price : $8.95]
ORA Office of Pharmaceutical Quality Operations director Alonza Cruse says FDA is prioritizing inspections of firms with the highest risk of finding compliance issues, including those that may have data integrity concerns.
03/31/2022
 
 
TXT Lupin Says 13 Observations in Novel Labs Inspection [2632 Words] [ Price : $8.95]
Lupin Pharmaceuticals says an FDA inspection at its Novel Laboratories subsidiary closed with 13 inspection observations.
03/31/2022
 
 
TXT Outlook Therapeutics BLA for Wet AMD Therapy [297 Words] [ Price : $8.95]
Outlook Therapeutics files a BLA for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration.
03/31/2022
 
 
TXT Medtronic Recalls IN.Pact Balloon Catheters [115 Words] [ Price : $8.95]
Medtronic recalls a subset of IN.Pact Admiral and IN.Pact AV paclitaxel-coated percutaneous transluminal angioplasty balloon catheters due to the potential for pouch damage and a resulting loss of sterility.
03/31/2022
 
 
TXT Donít Use FarmaKeio Superior Sterile Products: FDA [2672 Words] [ Price : $8.95]
FDA says patients and healthcare professionals should not use drugs purporting to be sterile produced by Richardson, TX-based FarmaKeio Superior Custom Compounding.
03/31/2022
 
 
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