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TXT No Imminent Retirement for Woodcock [168 Words] [ Price : $8.95]
FDA acting commissioner Janet Woodcock plans to play a senior role at the agency if FDA commissioner nominee Robert Califf is confirmed by the Senate.
12/03/2021
 
 
TXT Congress Should Revamp 510(k) Process: Opinion [729 Words] [ Price : $8.95]
A Yale and Harvard opinion piece says Congress should use the upcoming Cures 2.0 bill draft and the reauthorization of the medical device user fee program to effect meaningful change to the 510(k) clearance process.
12/03/2021
 
 
TXT FDA Update on Paclitaxel-Coated Balloons/Stents [384 Words] [ Price : $8.95]
FDA launches a new Web page about the safety of paclitaxel-coated balloons and paclitaxel-eluting stents that are approved to treat obstructed lesions in arteries of the legs.
12/03/2021
 
 
TXT Let Juries Hear ‘510(k) Evidence’: Attorney [2801 Words] [ Price : $8.95]
Attorney Phil Goldberg says the New Jersey Supreme Court should decide in two pelvic mesh liability cases that juries should hear evidence of FDA’s actions in clearing the devices.
12/02/2021
 
 
TXT FDA Providing Drug Info to Pregnant Women [2651 Words] [ Price : $8.95]
FDA updates consumers on its efforts to make more prescription drug information available to pregnant and breastfeeding women.
12/02/2021
 
 
TXT PhRMA Comments on Safety Reporting Guidance [2637 Words] [ Price : $8.95]
PhRMA says it appreciates the FDA approach in a draft guidance on investigator responsibility for safety reporting for investigational drugs and devices.
12/02/2021
 
 
TXT Sales Rep Settles False Claims Case [2664 Words] [ Price : $8.95]
The Justice Department says a self-employed medical device sales rep has agreed to pay $100,000 to resolve allegations he assisted in causing the submission of false claims.
12/02/2021
 
 
TXT Eating Disorder Tool Put in Class 2 [102 Words] [ Price : $8.95]
Federal Register notice: FDA classifies the conditioning tool for eating disorders into medical device Class 2 (special controls).
12/02/2021
 
 
TXT Class 2 for Esophageal Tissue Characterization [82 Words] [ Price : $8.95]
Federal Register notice: FDA classifies the esophageal tissue characterization system into Class 2 (special controls).
12/02/2021
 
 
TXT FDA Says More CBD Info Needed [2744 Words] [ Price : $8.95]
A CDER executive tells a hemp industry conference that FDA still needs more information before it can address the use of CBD in food and dietary supplements.
12/02/2021
 
 
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