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TXT Pharmacy Groups Want More Time on Supply Chain Rule [235 Words] [ Price : $8.95]
Three leading pharmacy organizations ask FDA to delay its enforcement of a 7/1 product tracing deadline in order to avoid unnecessary disruptions in the pharmaceutical supply chain.
06/25/2015
 
 
TXT Hospira India Facility Cleared by FDA [196 Words] [ Price : $8.95]
FDA approves a Hospira manufacturing facility in Visakhapatnam, India to make finished dosage drugs for the U.S.
06/25/2015
 
 
TXT Guidance on Injectable Drug/Biologic Excess Volume [89 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.
06/25/2015
 
 
TXT FDA Clears Exactech Optetrak Knee Prosthesis [213 Words] [ Price : $8.95]
FDA clears an Exactech, Inc. 510(k) for the Optetrak Logic Constrained Condylar Prosthesis for revision knee arthroplasty procedures.
06/25/2015
 
 
TXT FDA Looking at Role of Hearing Loss in Ads [263 Words] [ Price : $8.95]
FDA says it is proposing to study how age-related hearing loss affects older adults’ comprehension of the major statement in TV ads.
06/24/2015
 
 
TXT New Ways of Improving Drug Development Profiled [299 Words] [ Price : $8.95]
A Tufts Center for the Study of Drug Development white paper profiles four strategies drug companies are using to improve drug development efficiency and performance.
06/24/2015
 
 
TXT Device Liability Preemption Evolving: Attorney [438 Words] [ Price : $8.95]
Attorney Alan Minsk says there are several lessons to be learned about the shifting landscape of medical device preemption and off-label promotion from a recent 10th Circuit Appeals Court decision.
06/24/2015
 
 
TXT Physiochemical Properties Linked to Drug Safety Problems [385 Words] [ Price : $8.95]
Drug company researchers say that there is a link between drug compound physiochemical properties and clinical failure due to safety issues.
06/24/2015
 
 
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
 
 
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