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TXT Oxford Selling Unapproved, Misbranded Covid Items: FDA [2705 Words] [ Price : $8.95]
FDA warns Oxford Medical Instruments that it is marketing unapproved and misbranded new drugs and claiming they can treat Covid-19.
08/18/2020
 
 
TXT Changes to FDA Organization Structure [86 Words] [ Price : $8.95]
Federal Register notice: FDA revises its regulations to reflect changes to the agency’s organizational structure, including the reorganization of the Office of Regulatory Affairs.
08/18/2020
 
 
TXT Info Collection Extension on CVM Dispute Resolutions [145 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for CVM dispute resolution procedures.
08/18/2020
 
 
TXT BA, BE Sample Retention Compliance Guidance [2835 Words] [ Price : $8.95]
FDA publishes a guidance with its compliance policy on the retention of reserve samples of the test article and reference standard used in bioavailability or bioequivalence studies.
08/18/2020
 
 
TXT SilveryGuy Selling Unapproved Colloidal Silver: FDA [2750 Words] [ Price : $8.95]
FDA warns a Singapore-based Web site that it is selling an unapproved and misbranded colloidal silver drug product intended to treat Covid-19.
08/18/2020
 
 
TXT Notifying Applicants of Sentinel Analyses MAPP [5178 Words] [ Price : $8.95]
CDER issues a MAPP on policies and procedures for notifying NDA and BLA applicants about ARIA safety studies conducted in the Sentinel system.
08/18/2020
 
 
TXT Public Workshop on Orthopedic Device Infections [199 Words] [ Price : $8.95]
FDA announces an 11/13 public workshop on infections related to orthopedic devices and appropriate mitigation measures for protecting and promoting public health in this clinical area.
08/18/2020
 
 
TXT Latest FDA Warning Letters [374 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes AkivaMed, Oxford Medical Instruments and SilveryGuy.
08/18/2020
 
 
TXT Feds Charge Teva with Illegal Copaxone Kickbacks [2683 Words] [ Price : $8.95]
The Justice Department charges Teva with paying illegal kickbacks by funding foundations to channel company money to pay Medicare co-pays for patients taking Copaxone.
08/18/2020
 
 
TXT Priority Review for Alternative Imfinzi Dosing [123 Words] [ Price : $8.95]
FDA grants AstraZeneca a priority review for its supplemental BLA for Imfinzi (durvalumab) and a new four-week, fixed-dose regimen for treating approved indications for non-small cell lung cancer and bladder cancer.
08/18/2020
 
 
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