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Dont Use FarmaKeio Superior Sterile Products: FDA

[ Price : $8.95]

FDA says patients and healthcare professionals should not use drugs purporting to be sterile produced by Richardson, TX-based Farm...

FDA Wants to Change Generic Drug Exclusivity: Attorney

[ 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 ...

PQ/CMC Information Electronic Submission Project

[ Price : $8.95]

FDA describes progress to date on its project to identify and prioritize pharmaceutical quality/chemistry, manufacturing, and cont...

FDA OKs Edwards Mitral Heart Valve

[ Price : $8.95]

FDA approves Edwards Lifesciences Mitris Resilia valve, a tissue valve replacement specifically designed for the hearts mitral pos...

Magellan Resumes LeadCare II Distribution

[ 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 significa...

FDA Updates Covid Vaccine EUA Guidance

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FDA updates its guidance on materials to be submitted to support the issuance of an emergency use authorization for a Covid-19 vac...

Inspections Prioritized to Find Compliance/Data Integrity Issues

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ORA Office of Pharmaceutical Quality Operations director Alonza Cruse says FDA is prioritizing inspections of firms with the highe...

Lupin Says 13 Observations in Novel Labs Inspection

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Lupin Pharmaceuticals says an FDA inspection at its Novel Laboratories subsidiary closed with 13 inspection observations.

Outlook Therapeutics BLA for Wet AMD Therapy

[ Price : $8.95]

Outlook Therapeutics files a BLA for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration.

Medtronic Recalls IN.Pact Balloon Catheters

[ Price : $8.95]

Medtronic recalls a subset of IN.Pact Admiral and IN.Pact AV paclitaxel-coated percutaneous transluminal angioplasty balloon cathe...