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TXT FDA Grants Priority Status for Gastrointestinal Sealant [69 Words] [ Price : $8.95]
FDA grants priority review for Cohera Medicalís Sylys Surgical Sealant to help reduce anastomotic leakage in gastrointestinal procedures.
12/17/2014
 
 
TXT Voss Plastics Warned About QS Violations [389 Words] [ Price : $8.95]
FDAís Dallas District Office warns Voss Plastics about Quality System and Medical Device Reporting violations in its manufacturing of disposable coronary bypass cannulas.
12/16/2014
 
 
TXT FDA Proposes Rule on E-prescribing Information [195 Words] [ Price : $8.95]
FDA issues a proposed rule to require electronic distribution of the prescribing information intended for health care professionals.
12/16/2014
 
 
TXT Maisel Lists CDRH Strategic Priorities [339 Words] [ Price : $8.95]
CDRH deputy director for science William Maisel says the Center is working to ensure that U.S. patients are the first in the world to gain access to new technology through an improved clinical trial improvement process.
12/16/2014
 
 
TXT Patient Voices Introduce Bias: Commentator [346 Words] [ Price : $8.95]
Drug industry commentator David Grainger says listening to patient advocacy groups can bring a bias into healthcare decision-making about resource allocation.
12/16/2014
 
 
TXT FDA Clears Bovie Medical Surgical Generator [103 Words] [ Price : $8.95]
FDA clears a Bovie Medical 510(k) for its Bovie Ultimate generator, a high-frequency electrosurgical generator that can be used for delivering radiofrequency energy or helium gas plasma to cut, coagulate and ablate soft tissue.
12/16/2014
 
 
TXT DoJ Nixes Prosecution of Pair Who Used Unapproved Drugs in Practice [186 Words] [ Price : $8.95]
The U.S. Justice Department drops a case against physician Anindya Kumar Sen and his wife and practice manager Patricia Posey Sen (both of Greeneville, TN) that alleged they caused the introduction of misbranded drugs into interstate commerce.
12/16/2014
 
 
TXT 2 Innovations Can Change Drug Production: Consultants [449 Words] [ Price : $8.95]
Consultants Marcus Ehrhardt and Peter Behner say two drug production innovations will significantly change the currently stagnant drug manufacturing process.
12/16/2014
 
 
TXT Point-of-Care Communication Channel Growing: Consultants [281 Words] [ Price : $8.95]
A ZS Associates study says point-of-care communications is growing much faster than overall direct-to-consumer communications.
12/16/2014
 
 
TXT FDA Approves Novartisís Signifor for Treating Acromegaly [179 Words] [ Price : $8.95]
FDA approves a Novartis NDA for Signifor (pasireotide) long-acting release for treating patients with acromegaly who have had an inadequate response to surgery or for whom surgery is not an option.
12/16/2014
 
 
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