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TXT Regulatory Review Period for Shionogi’s Symproic [107 Words] [ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for Shionogi’s Symproic (naldemedine tosylate) for treating opioid-induced constipation in adult patients with chronic non-cancer pain.
04/12/2019
 
 
TXT Class 2 for Ventilatory Electrical Impedance Tomograph [76 Words] [ Price : $8.95]
Federal Register notice: Based on a de novo request, FDA classifies Timpel’s Enlight 1810 ventilatory electrical impedance tomograph into Class 2.
04/12/2019
 
 
TXT Merck’s Keytruda Gains Added Monotherapy Use [111 Words] [ Price : $8.95]
FDA approves an expanded label for Merck’s Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of certain patients with Stage 3 non-small cell lung cancer.
04/12/2019
 
 
TXT Device Accessories Into Class 1 [102 Words] [ Price : $8.95]
Federal Register notice: FDA classifies suitable medical device accessories into Class I as required by the FDA Reauthorization Act of 2017.
04/12/2019
 
 
TXT Ex-Pharmakon CEO Convicted on FDA Fraud, Adulteration [275 Words] [ Price : $8.95]
Former Pharmakon Pharmaceuticals CEO Paul J. Elmer and compliance director Caprice R. Bearden are convicted of conspiracy to defraud FDA and nine counts of adulterating drugs at the company’s Noblesville, IN drug compounding facility.
04/12/2019
 
 
TXT ‘High Concern’ Duodenoscope Contamination Rates Rise [376 Words] [ Price : $8.95]
A new FDA update says the findings from duodenoscope studies now show that up to 5.4% of all properly collected samples tested positive for “high concern” organisms, which is significantly higher than the earlier 3% reported.
04/12/2019
 
 
TXT Janssen Accelerated Approval for Bladder Cancer Therapy [280 Words] [ Price : $8.95]
FDA grants Janssen Pharmaceutical an accelerated approval for Balversa (erdafitinib), a treatment for certain adult patients with locally advanced or metastatic bladder cancer.
04/12/2019
 
 
TXT FDA Mitigating Pediatric Tracheostomy Tubes Shortage [141 Words] [ Price : $8.95]
FDA says it is helping to mitigate a temporary shortage of pediatric breathing tubes due to the recent closure of Sterigenics’s Willowbrook, IL sterilization facility.
04/12/2019
 
 
TXT FDA Extends Comment Period on 510(k) Modernization [362 Words] [ Price : $8.95]
FDA extends the comment period by 30 days for its Modernizing the Food and Drug Administration's 510(k) Program: Request for Comments regarding FDA’s proposal to consider making public on its Web site cleared devices that demonstrated substantial equivalence to older predicate devices.
04/11/2019
 
 
TXT Final Rule on OTC Hand Sanitizers [83 Words] [ Price : $8.95]
Federal Register final rule: FDA rules that certain active ingredients are not allowed to be used in OTC hand sanitizers.
04/11/2019
 
 
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