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TXT Government OKs Texas Influenza-Vaccine Facility [150 Words] [ Price : $7.95]
HHS approves an influenza vaccines manufacturing facility in Bryan-College Station, TX as part of a partnership between GlaxoSmithKline and Texas A&M University and the Center for Innovation in Advanced Development and Manufacturing.
03/26/2013
 
 
TXT FDA Sends Info on Supplement Labeling to OMB [53 Words] [ Price : $7.95]
Federal Register Notice: FDA submits a proposed collection to the Office of Management and Budget on food labeling and notification procedures for statements on dietary supplements.
03/26/2013
 
 
TXT FDA Won’t Change Mesalamine Bio Recommendations [241 Words] [ Price : $7.95]
FDA denies a Warner Chilcott petition asking that it change its bioequivalence recommendations for generic versions of orally-ingested modified-release mesalamine drugs.
03/26/2013
 
 
TXT IoM Workshop Examines Hurdles to Advancing Personalized Medicine [487 Words] [ Price : $7.95]
An Institute of Medicine workshop examines human genome sequencing and the identification of links between specific genetic variants and diseases and their potential to direct patient.
03/26/2013
 
 
TXT Inspection Finds QS Problems at Instratek [221 Words] [ Price : $7.95]
FDA’s Dallas District Office warns Instratek about QS violations in its Houston, TX, manufacturing facility.
03/26/2013
 
 
TXT QS Violations Found at Fresenius Facility [122 Words] [ Price : $7.95]
FDA’s Denver District Office warns Fresenius about QS violations at its Ogden, UT, manufacturing plant.
03/26/2013
 
 
TXT Multiple QS, MDR Violations Found at Italy’s Fisioline [398 Words] [ Price : $7.95]
FDA warns Italian laser device manufacturer Fisioline about multiple QS and MDR violations in its manufacturing facility.
03/26/2013
 
 
TXT FDA Updates CDRH Address in Regs [68 Words] [ Price : $7.95]
Federal Register Final rule: FDA amends a final rule to reflect an office relocation for CDRH.
03/26/2013
 
 
TXT FDA Orphan Drug Status for Acceleron Blood Disorder Drug [219 Words] [ Price : $7.95]
FDA grants Acceleron Pharma two orphan drug designations for ACE-536 for treating beta-thalassemia and myelodysplastic syndromes, two rare blood disorders characterized by severe and chronic anemia.
03/26/2013
 
 
TXT FDA Posts Spacelabs’ Anesthesia Workstation Class 1 Recall [105 Words] [ Price : $7.95]
FDA posts a Class 1 recall notice on Spacelabs’ BleaseSirius Anesthesia Workstation due to a defect in the device’s CAS I/II Absorbers that may cause a condition leading to an increase in the carbon dioxide concentration.
03/26/2013
 
 
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