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TXT Amgen sBLA Approved for Cardiovascular Risk Reduction [127 Words] [ Price : $8.95]
FDA approves an Amgen supplemental BLA for Repatha (evolocumab) for preventing heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.
12/04/2017
 
 
TXT FDA Approves Lilly’s Taltz for Psoriatic Arthritis [104 Words] [ Price : $8.95]
FDA approves Eli Lilly’s Taltz (ixekizumab) injection 80 mg/mL for treating adults with active psoriatic arthritis.
12/04/2017
 
 
TXT Additions to Device Consensus Standards [94 Words] [ Price : $8.95]
Federal Register notice: FDA announces six modifications the agency is making to its FDA-Recognized Consensus Standards listing for use in premarket reviews.
12/04/2017
 
 
TXT FDA Guidance on 3-D Printing Plans for Future Innovations [623 Words] [ Price : $8.95]
FDA issues a new guidance on “Technical Considerations for Additive Manufactured Medical Devices 3D Printing of Medical Devices” that is intended to prepare for forthcoming innovations in this area.
12/04/2017
 
 
TXT FDA Reclassifies/Renames Female Condom [97 Words] [ Price : $8.95]
Federal Register notice: FDA proposes to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a postamendments Class 3 device, into Class 2 (special controls) subject to 510(k) clearance.
12/04/2017
 
 
TXT Guide on IDE Categorization for CMS Coverage Decisions [247 Words] [ Price : $8.95]
FDA issues a guidance on “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions,” which modifies the categorization of IDE devices used in clinical studies.
12/04/2017
 
 
TXT Pharmaceutical Site Visit Program Seeks Proposals [74 Words] [ Price : $8.95]
Federal Register notice: CDER announces its intent to accept proposals from pharmaceutical companies interested in participating in the Office of Pharmaceutical Quality’s Staff Experiential Learning Site Visit Program.
12/04/2017
 
 
TXT Gottlieb to Meet with Lawmakers on Essure Concerns [521 Words] [ Price : $8.95]
FDA commissioner Scott Gottlieb agrees to meet with Rep. Rosa DeLauro (D-CT) and other members of Congress to discuss the safety of Bayer’s controversial contraceptive implant Essure.
12/04/2017
 
 
TXT FDA Approves Cancer Biomarker Test [1355 Words] [ Price : $8.95]
FDA approves Foundation Medicine’s F1CDx next generation sequencing cancer biomarker test.
12/01/2017
 
 
TXT FDA Approves Mylan’s Herceptin Biosimilar [202 Words] [ Price : $8.95]
FDA approves Mylan’s Ogivri (trastuzumab-dkst), the first biosimilar to Genentech’s Herceptin, indicated for treating patients with breast or metastatic stomach cancer whose tumors over-express the HER2 gene.
12/01/2017
 
 
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