HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS

Welcome to FDAweb Pay Per View Search our 61,953 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers            1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   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     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     ‘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     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     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     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     Draft Guide on Limited Population Pathway [61 Words] [ Price : $8.95] Federal Register notice: FDA makes available a draft guidance entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.” 06/13/2018     FDA Declines scPharmaceuticals NDA for Furoscix [76 Words] [ Price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     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     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       1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com