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TXT Flume Balloon Urinary Catheter Cleared [68 Words] [ Price : $8.95]
FDA clears a Flume Catheter Co. 510(k) for its Flume urinary balloon catheter.
11/04/2021
 
 
TXT Woodcock Sets High Priority for OTC Covid Tests [693 Words] [ Price : $8.95]
FDA acting commissioner Janet Woodcock testifies before Congress about an agency priority to increase the availability of over-the-counter Covid-19 home tests.
11/04/2021
 
 
TXT FDA Updates Hill on Covid Therapies, Inspections [700 Words] [ Price : $8.95]
FDA testimony at a Senate hearing on Covid-19 discusses the unprecedented number of new product submissions to fight the disease and new manufacturing oversight options in lieu of physical inspections.
11/04/2021
 
 
TXT Diabetes Treatment Goal Can Cause Problems: Reuters [2937 Words] [ Price : $8.95]
A Reuters series documents the role diabetes drug marketing techniques played in a significant increase in cases of hypoglycemia among diabetics trying to achieve a goal of A1c 7% or lower.
11/04/2021
 
 
TXT FDA Fast Track for TransThera Drug [2637 Words] [ Price : $8.95]
FDA grants fast track designation to TransThera Science’s experimental Phase 2 cholangiocarcinoma drug.
11/03/2021
 
 
TXT 10-item FDA-483 to Innoveix Pharmaceuticals [118 Words] [ Price : $8.95]
An FDA inspection leads to a 10-item Form FDA-483 issued to Innoveix Pharmaceuticals that took issue with the firm’s GMPs for sterile drug products.
11/03/2021
 
 
TXT Software Function Premarket Submission Guidance [2670 Words] [ Price : $8.95]
FDA publishes a draft guidance on recommended documentation for premarket submissions of medical device software functions.
11/03/2021
 
 
TXT FDA Evaluating Compounding MOU Court Action [2770 Words] [ Price : $8.95]
FDA says it is evaluating a DC federal court ruling remanding to the agency its memorandum of understanding with states on the interstate distribution of compounded drugs.
11/03/2021
 
 
TXT Adakveo Regulatory Review Period Determined [87 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novartis’ Adakveo (crizanlizumab-tmca).
11/03/2021
 
 
TXT Dengvaxia Regulatory Review Period Determined [103 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sanofi’s Dengvaxia (dengue tetravalent vaccine, live).
11/03/2021
 
 
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