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TXT Lawyers Predict Gottlieb ‘Imminent Confirmation’ [528 Words] [ Price : $8.95]
An Epstein Becker & Green client alert predicts an “imminent confirmation” of Scott Gottlieb to be the next FDA commissioner, which should be a win for industry based on his support of “flexible systemic approaches to shorten review timelines and bring more products to market.”
04/14/2017
 
 
TXT FDA Clears Esophageal Cooling Device [89 Words] [ Price : $8.95]
FDA clears an Advanced Cooling Therapy 510(k) for use of its Esophageal Cooling Device with the Altrix Precision Temperature Management System by Stryker.
04/14/2017
 
 
TXT Courts Narrowing Liability Under False Claims Act [2757 Words] [ Price : $8.95]
Two attorneys say a recent Pennsylvania federal court decision shows courts are narrowing the situations in which they impose liability under the False Claims Act.
04/13/2017
 
 
TXT FDA Clears Additive Orthopedics Plating System [102 Words] [ Price : $8.95]
FDA clears an Additive Orthopedics 510(k) for its 3D printed Locking Lattice Plating System and its use to address stabilization and fusion of fractures, osteotomies, and arthrodesis of small bones.
04/13/2017
 
 
TXT FDA Clears Entellus ENT Dilation System [109 Words] [ Price : $8.95]
FDA clears an Entellus Medical 510(k) for the XprESS ENT Dilation System and its use in patients with persistent Eustachian tube dysfunction.
04/13/2017
 
 
TXT Few Cancer Drugs to Work with Radiation: FDA Staff [2708 Words] [ Price : $8.95]
CDER Office of Hematology and Cancer Products staff list possible reasons why only one drug has been approved since 2006 for use with radiation in curative or palliative cancer treatment.
04/13/2017
 
 
TXT FBI Warns of FTP Cybersecurity Risk [2690 Words] [ Price : $8.95]
Attorney Kate Stewart says the FBI is warning about the cybersecurity risk in FTP servers in healthcare facilities operated in an anonymous configuration.
04/13/2017
 
 
TXT Comment Period Extended on Animal DNA Guidance [87 Words] [ Price : $8.95]
Federal Register notice: FDA extends the comment period for the draft guidance for industry #187 “Regulation of Intentionally Altered Genomic DNA in Animals” that was announced in the 1/19 Federal Register.
04/13/2017
 
 
TXT FDA Exempts 71 Class 1 Devices from 510(k) Submissions [137 Words] [ Price : $8.95]
Federal Register notice: FDA identifies 71 Class 1 devices that are now exempt from premarket notification requirements.
04/13/2017
 
 
TXT REMS No Longer Needed for Amgen’s Anemia Drugs: FDA [265 Words] [ Price : $8.95]
FDA determines that Amgen’s erythropoiesis-stimulating agents epoetin alfa (Procrit and Epogen) and darbepoetin alfa (Aranesp) no longer require a Risk Evaluation and Mitigation Strategy.
04/13/2017
 
 
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