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TXT Justice Department Probe on Philips Respironics Recall [1131 Words] [ Price : $8.95]
The Department of Justice subpoenas Philips Respironics and certain other Philips subsidiaries in the U.S. for information on the events that led to the recall of certain ventilators, continuous positive airway pressure and bilevel positive airway pressure machines.
04/26/2022
 
 
TXT Export Notification/Recordkeeping Info Collection [96 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled “Export Notification and Recordkeeping Requirements.”
04/25/2022
 
 
TXT Autofluorescence Detection Device is Class 2 [117 Words] [ Price : $8.95]
Federal Register notice: FDA classifies the autofluorescence detection device for general surgery and dermatological use into Class 2 (special controls).
04/25/2022
 
 
TXT FDA Hits Wedgewood Connect with 483 After Inspection [113 Words] [ Price : $8.95]
FDA issues a four-item Form FDA-483 to Wedgewood Connect after an inspection of its San Jose, CA drug manufacturing facility cited significant GMP violations.
04/25/2022
 
 
TXT Xenotransplantation Guide Information Collection [91 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled “Public Health Service (PHS) Guideline on Infectious Disease Issues in Xenotransplantation.”
04/25/2022
 
 
TXT FDA Probes DTC Promotional Claims ‘Tradeoffs’ [423 Words] [ Price : $8.95]
CDER's Office of Prescription Drug Promotion seeks comments on a research proposal to understand the “Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion.”
04/25/2022
 
 
TXT CMC Issues Hinder Axsome NDA on Migraine Drug [286 Words] [ Price : $8.95]
Axsome Therapeutics expects to receive a complete response letter on its NDA for migraine drug AXS-07 (meloxicam-rizatriptan) due to FDA-identified chemistry, manufacturing, and controls issues.
04/25/2022
 
 
TXT Lab Test Firms, Others Plead Guilty in Kickback Scheme [267 Words] [ Price : $8.95]
Eleven defendants, including the founders of several lab companies, plead guilty in a $300 million scheme to pay kickbacks to induce medical professionals to order medically unnecessary lab tests.
04/25/2022
 
 
TXT Gilead’s Veklury OK’d for Covid Pediatric Patients [98 Words] [ Price : $8.95]
FDA expands the approval of Gilead Sciences’ Veklury (remdesivir) to include treating Covid-19 pediatric patients 28 days of age and older weighing at least 3 kilograms.
04/25/2022
 
 
TXT Ardelyx Gets Panel Review on Tenapanor Appeal [234 Words] [ Price : $8.95]
CDER’s Office of New Drugs says it will convene its Cardiovascular and Renal Drug Advisory Committee to hear an appeal from Ardelyx of a complete response letter on an NDA for tenapanor to control serum phosphorus in chronic kidney disease patients on dialysis.
04/25/2022
 
 
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