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TXT Senators Question FDA Animal Antibiotic Authority [611 Words] [ Price : $8.95]
Sens. Warren, Feinstein, and Gillibrand ask the secretaries of HHS, Agriculture, and Defense questions about FDAís authority to monitor reductions in antibiotic use in feed animals.
12/17/2014
 
 
TXT Hamburg Touts FDA Steps on Compounded Drugs [376 Words] [ Price : $8.95]
FDA commissioner Margaret Hamburg says the agency is moving forward on several fronts to prevent a repeat of contaminated compounded drug problems.
12/17/2014
 
 
TXT Pozen Gets 2nd Complete Response Letter on Yosprala [260 Words] [ Price : $8.95]
FDA issues Pozen a second complete response letter (CRL)on its NDA for Yosprala (aspirin and omeprazole) delayed release tablets, indicated for use as secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
12/17/2014
 
 
TXT FDA Clears Sorinís Memo 3D ReChord Annuloplasty Ring [98 Words] [ Price : $8.95]
FDA clears Sorin Groupís Memo 3D ReChord annuloplasty ring for mitral valve repair.
12/17/2014
 
 
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
 
 
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