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Welcome to FDAweb Pay Per View Search our 72,047 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 Next >>   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     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     FDA OK’s Edwards Mitral Heart Valve [196 Words] [ Price : $8.95] FDA approves Edwards Lifesciences’ Mitris Resilia valve, a tissue valve replacement specifically designed for the heart’s mitral position. 03/31/2022     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     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     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     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     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     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     Don’t 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     << Prev  24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43  Next >>

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