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TXT Meeting the 510(j)(3) Reporting Requirement [2768 Words] [ Price : $8.95]
Two Wiley Rein attorneys suggest ways companies could approach the new FDA section 510(j)(3) drug reporting requirement.
11/17/2021
 
 
TXT SterRx Recalls 240 Drug Lots Over Sterility [309 Words] [ Price : $8.95]
SterRx recalls 240 lots of various drug products within their expiry period due to equipment and process issues that could lead to a lack of sterility assurance.
11/17/2021
 
 
TXT FDA Clears Pantheris for In-stent Restinosis [297 Words] [ Price : $8.95]
FDA clears an Avinger 510(k) for a new clinical indication for the Pantheris image-guided atherectomy system — treating in-stent restenosis in the lower extremity arteries.
11/17/2021
 
 
TXT 18 No-Longer-Marketed ANDAs Withdrawn [51 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws approval of 18 ANDAs from multiple applicants after they notified the agency that the drugs were no longer marketed.
11/17/2021
 
 
TXT Disqualify 2 Minnesota Researchers: Public Citizen [2787 Words] [ Price : $8.95]
Public Citizen says FDA should disqualify from conducting clinical trials two doctors at the Hennepin County Medical Center and the center’s institutional review board.
11/17/2021
 
 
TXT Fast Track for AstraZeneca Lokelma Indication [2642 Words] [ Price : $8.95]
FDA grants fast track designation to AstraZeneca’s hyperkalemia drug Lokelma to reduce arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia.
11/17/2021
 
 
TXT FDA Qualifies MED Institute MRI Safety Tool [2621 Words] [ Price : $8.95]
FDA qualifies the MED Institute’s medical device development tool for virtual MRI safety evaluations of patients with implanted medical devices.
11/17/2021
 
 
TXT FDA Clears MIM Molecular Radiotherapy Software [72 Words] [ Price : $8.95]
FDA clears a MIM Software 510(k) for its MIM SurePlan MRT, a software package for molecular radiotherapy.
11/17/2021
 
 
TXT Changes for Electronic Submission Guidance [2729 Words] [ Price : $8.95]
Cook Group recommends improvements to an FDA draft guidance on the electronic submission eSTAR template.
11/16/2021
 
 
TXT Blackrock Neurotech Breakthrough Status for Brain Interface [92 Words] [ Price : $8.95]
FDA grants Blackrock Neurotech a breakthrough device designation for its MoveAgain Brain Computer Interface System that is intended to provide immobile patients the ability to control a computer, wheelchair or prosthetic device by thinking.
11/16/2021
 
 
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