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TXT FDA Approves St. Jude Flexible Catheter [104 Words] [ Price : $8.95]
FDA approves a St. Jude Medical PMA for the FlexAbility Ablation Catheter for use in treating cardiac arrhythmias.
01/28/2015
 
 
TXT Obama Doubling Funding Request for Fighting Antibiotic Resistance [1504 Words] [ Price : $8.95]
The Obama administration says it will ask for $1.2 million in next week’s annual budget request to double the amount the government now spends to help curb antibiotic-resistant bacteria.
01/27/2015
 
 
TXT Unapproved Drug, Other Violations at Chaga Mountain [613 Words] [ Price : $8.95]
FDA’s New England District Office warns Chaga Mountain it is selling unapproved new drugs and not following Current Good Manufacturing Practice regulations for dietary supplements.
01/27/2015
 
 
TXT Comments Sought on Biosimilars Form [40 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on the collection of information in the Biosimilars User Fee Cover Sheet.
01/27/2015
 
 
TXT Info on Condom Labeling Sent to OMB [57 Words] [ Price : $8.95]
Federal Register Notice: FDA’s proposed collection of information on a Class 2 Special Controls guidance on natural rubber latex condom labeling has been submitted to the Office of Management and Budget.
01/27/2015
 
 
TXT FDA Posts Changes to List of Recognized Device Standards [75 Words] [ Price : $8.95]
Federal Register Notice: FDA is announcing a publication containing modifications it is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards).
01/27/2015
 
 
TXT ICH Guidance on Photosafety Evaluation of Pharmaceuticals [106 Words] [ Price : $8.95]
Federal Register Notice: FDA releases an ICH guidance: S10 Photosafety Evaluation of Pharmaceuticals.
01/27/2015
 
 
TXT Guidance on Treating Fungally-Infected Nails [82 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.
01/27/2015
 
 
TXT Workshop on Food Effect Assessment [145 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a public workshop 2/2-4: “Evaluating and Modernizing our Approaches for Food-Effect Assessment.
01/27/2015
 
 
TXT FDA, Xavier U. Plan PharmaLink Conference [118 Words] [ Price : $8.95]
Federal Register Notice: FDA and Xavier University plan a public conference 3/25-27: FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.”
01/27/2015
 
 
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