Dural repairs with spinal sealants

Spine Journal

Volumn 12, Issue 3, 2012, Pages 279-

  Woo, Emily Jane ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FIBRIN GLUE;

CLINICAL EFFECTIVENESS; DRUG APPROVAL; DURAPLASTY; HEMATOMA; HUMAN; INFECTION; LETTER; LIQUORRHEA; MENINGITIS; NEUROSURGERY; OFF LABEL DRUG USE; PRIORITY JOURNAL; SAFETY; SEROMA;

DURA MATER; HUMANS; TISSUE ADHESIVES;

EID: 84859323085     PISSN: 15299430     EISSN: 18781632     Source Type: Journal    
DOI: 10.1016/j.spinee.2012.01.017     Document Type: Letter

References (7)

1. N.E. Epstein Dural repair with four spinal sealants: focused review of the manufacturers' inserts and the current literature Spine J 10 2010 1065 1068
2. N.E. Epstein BioGlue and spine surgery (author reply) Spine J 11 2011 983 984
3. M. Miscusi BioGlue and spine surgery Spine J 11 2011 983
4. Food and Drug Administration. "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices - Information Sheet. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126486.htm. Accessed February 19, 2012.
5. R.S. Stafford Regulating off-label drug use - rethinking the role of the FDA N Engl J Med 358 2008 1427 1429 (Pubitemid 351482734)
6. B. Abuzayed, H. Erman, and M. Inan Acute mass formation of BioGlue after spinal dural repair: a glue-oma case report Neurosurgery Q 20 2010 253 255
7. Food and Drug Administration. Potential signals of serious risks/new safety information identified by the Adverse Event Reporting System (AERS) between January - March 2011. Available at: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ ucm258366.htm. Accessed February 19, 2012.