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TXT Medtronic Recalls Covidien Shiley Tracheostomy Tubes [146 Words] [ Price : $8.95]
After customer complaints including reports of breathing difficulties, Medtronic recalls certain lots of its Covidien Shiley tracheostomy tubes that were formed with a wider-angle bend than standard models.
06/24/2015
 
 
TXT FDA Says Amarin Conducting ‘Frontal Assault’ on NDA Framework [378 Words] [ Price : $8.95]
FDA says Amarin’s First Amendment-based lawsuit over off-label information dissemination is a “frontal assault” on the new drug approval framework that Congress created in 1962.
06/24/2015
 
 
TXT FDA Approves Cochlear Sound Processor for Older Implant [98 Words] [ Price : $8.95]
FDA approves Cochlear Ltd.’s Nucleus 6 Sound Processor for use with the Nucleus 22 Cochlear Implant, which will allow those who have worn cochlear implants for years access to the latest hearing technology.
06/24/2015
 
 
TXT FDA Approves Esophageal Cooling Device [333 Words] [ Price : $8.95]
FDA approves an Advanced Cooling Therapy de novo petition to allow the marketing of the Esophageal Cooling Device (ECD), a temperature modulation device that uses the esophageal space to cool or warm patients.
06/24/2015
 
 
TXT Vanda Plans sNDA for Schizophrenia Drug Fanapt [155 Words] [ Price : $8.95]
Vanda Pharmaceuticals says it will file later this year a supplemental NDA on its schizophrenia drug Fanapt (iloperidone) to include “positive results” from the long-term maintenance REPRIEVE clinical study.
06/24/2015
 
 
TXT FDA Safety Alert on Daytrana ADHD Patch [157 Words] [ Price : $8.95]
A new FDA drug safety alert warns that Noven Pharmaceuticals’ Daytrana patch (methylphenidate transdermal system) for attention deficit hyperactivity disorder has been associated with reports of permanent loss of skin color.
06/24/2015
 
 
TXT CBO Budget Scoring of Cures Bill Costs FDA $872 Million [261 Words] [ Price : $8.95]
The Congressional Budget Office scores the House of Representatives’ 21st Century Cures Act and determines that the bill would cost FDA $872 million over its five-year implementation period.
06/24/2015
 
 
TXT Stakeholders Offer More GDUFA Policy Ideas [504 Words] [ Price : $8.95]
Stakeholders submit additional comments to a reopened FDA docket on policy development under the Generic Drug User Fee Act.
06/24/2015
 
 
TXT Excess Volume, Labeled Fill Size Guidance [300 Words] [ Price : $8.95]
CDER and CBER publish an updated guidance on allowable excess volume and labeled vial fill size for some injectable drug products.
06/24/2015
 
 
TXT FDA Clears PeriCoach System for Pelvic Muscles [93 Words] [ Price : $8.95]
FDA clears an Analytica Limited 510(k) for the PeriCoach System, a device and smartphone app intended to help women perform at-home pelvic floor muscle training for treating urinary incontinence.
06/23/2015
 
 
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