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TXT FDA Clears Gold Standard Diagnostics Lyme Assay [78 Words] [ Price : $8.95]
FDA clears a Gold Standard Diagnostics 510(k) for its Borrelia burgdorferi IgG/IgM ELISA Lyme assay.
06/13/2018
 
 
TXT Generic Drug Industry Challenges Aired [2682 Words] [ Price : $8.95]
FDA and generic drug industry representatives shared insights on threats to the industry and elements of the GDUFA 2 commitment letter during an implementation meeting.
06/13/2018
 
 
TXT ‘Least Burdensome’ Mandatory Training Held [2720 Words] [ Price : $8.95]
FDA reports to Congress on its activities to implement a Cures Act requirement for mandatory staff training on medical device least burdensome principles.
06/13/2018
 
 
TXT Alternative Mechanisms for Combo Product GMP Compliance [74 Words] [ Price : $8.95]
Federal Register notice: FDA issues a proposed list of alternative or streamlined mechanisms for complying with GMP requirements for combination products.
06/13/2018
 
 
TXT Guide on Health Care Economic Information Communications [130 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers.”
06/13/2018
 
 
TXT Guide on Medical Product Communications Q & A [119 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a guidance for industry entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers.”
06/13/2018
 
 
TXT Draft Guide on Limited Population Pathway [61 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.”
06/13/2018
 
 
TXT FDA Declines scPharmaceuticals NDA for Furoscix [76 Words] [ Price : $8.95]
FDA issues scPharmaceuticals a complete response letter on its 505(b)(2) NDA for Furoscix (subcutaneous furosemide) for treating edema or fluid overload in patients with heart failure.
06/13/2018
 
 
TXT Avastin Approved for Combo Use in Ovarian Cancer [129 Words] [ Price : $8.95]
FDA approves Genentech’s Avastin (bevacizumab) for use in combination with chemotherapy, followed by Avastin as a single agent, for treating women with advanced ovarian cancer following initial surgical resection.
06/13/2018
 
 
TXT Wright Medical PMA Approved for Augment Bone Graft [79 Words] [ Price : $8.95]
FDA approves a Wright Medical Group PMA for Augment Bone Graft for use in hindfoot and ankle fusion.
06/13/2018
 
 
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