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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.
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.
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.
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Some stakeholders challenge the basis for some impacts of an FDA draft guidance on the de novo classification of medical devices.
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.
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.
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.
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.
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.
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.
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