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TXT Pharmacists Most Comfortable with Biosim Nonproprietary Names [376 Words] [ Price : $8.95]
Researchers say that most pharmacists they surveyed would be most comfortable substituting biosimilars that contain the same active ingredient and nonproprietary name as the reference product.
03/26/2015
 
 
TXT CDRH Compliance Office Given Law Firm’s Essure Petition [288 Words] [ Price : $8.95]
CDRH closes a complaint against Bayer about its Essure product because it is a trade complaint that is being referred to the Center’s Office of Compliance.
03/26/2015
 
 
TXT FDA Clears Stryker LITe Plate for Interbody Fusion [62 Words] [ Price : $8.95]
FDA clears a Stryker 510(k) for the LITe Plate System, an anterior and lateral lumbar plate system intended for use in anterior lumbar interbody fusion procedures.
03/26/2015
 
 
TXT FDA Challenged on De Novo Guidance [758 Words] [ Price : $8.95]
Some stakeholders challenge the basis for some impacts of an FDA draft guidance on the de novo classification of medical devices.
03/26/2015
 
 
TXT Sanofi Pasteur Quadracel Vaccine Approved [107 Words] [ Price : $8.95]
FDA approves a Sanofi Pasteur BLA for Quadracel vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children aged four to six.
03/26/2015
 
 
TXT ‘Wildly Overestimated’ Harm from Labeling Reg: Analysis [495 Words] [ Price : $8.95]
An economic analysis commissioned by trial lawyers finds that generic drug companies are “wildly” over-estimating the financial impact of a draft FDA rule that would require them to update drug labeling with new safety information.
03/26/2015
 
 
TXT Olympus Revises Reprocessing Instructions for Duodenoscopes [139 Words] [ Price : $8.95]
Olympus issues new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope to replace those provided in its original labeling.
03/26/2015
 
 
TXT CDRH, MED Institute Researching Implant RF Safety [217 Words] [ Price : $8.95]
CDRH and Cook Group’s MED Institute collaborate to research radio frequency-induced heating of passive metallic medical devices during MRIs.
03/25/2015
 
 
TXT Blog Supports FAST Generics Act Concepts [505 Words] [ Price : $8.95]
A Health Affairs blog post calls on Congress to create a safe harbor so that patent infringement claims can’t be brought against a generic drug company for replicating the REMS of a branded drug for a bioequivalent generic.
03/25/2015
 
 
TXT New Trial in Device Preemption Case [344 Words] [ Price : $8.95]
Attorney Barry Levenstam says the 9th Circuit Court of Appeals has ruled that a case against an I-Flow infusion pump can go to trial because state law jury instructions were not preempted since they were not based on fraud against FDA.
03/25/2015
 
 
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