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City New York City / / Company IgG / Genzyme / / Event FDA Phase / / Facility Mt. Sinai Medical Center / / IndustryTerm clear solution / treatment for Fabry's disease / trial protocol / galactosidase product / dose / treatment for Gaucher’s disease / proposed commercial manufacturing process / treatment of Fabry's disease / / MedicalCondition another inherited enzyme deficiency / strokes / seizures / added hypersensitivity / cardiomegaly / Fabry’s disease / angiokeratoma / Renal disease / diarrhea / transient ischemic attacks / proteinuria / hypertension / lymphedema / disease / mitral insufficiency / intense burning pains / ganglion / Fabry's disease / progressive azotemia / recessive deficiency / skeletal deformities / pain in the arms and legs / pain / myocardial infarction / Gaucher’s disease / clinically significant organic disease / hypohidrosis / deficiency / renal failure / Paresthesias / anemia / BACKGROUND Fabry's disease / / MedicalTreatment kidney transplantation / intravenous infusion / dialysis / / NaturalFeature Mt. Sinai / / Organization Food and Drug Administration Center for Biologics Evaluation and Research / Division of Clinical Trial Design / Mt. Sinai Medical Center / United States Adopted Names council / DEPARTMENT OF HEALTH / / Person Marc Walton / J. Charles Jennette / James Kaiser / / Position investigator / Independent pathologist / chief / pathologist / Medical Officer / / Product Cerezyme / carbamazepine / mannitol / sterile water for injection / phenytoin / Concomitant medication / AGAL-1-002 / GL-3 / STN103979 / / ProvinceOrState Maryland / / PublishedMedium Baseline / / Technology Alpha / transplantation / MRI / Pharmacokinetics / laser / Analysis The protocol / 25 Protocol / OF TRIAL The trial protocol / pharmacodynamics / 56 Protocol / 2 Protocol / dialysis / / SocialTag 
DEPARTMENT OF HEALTH & HUMAN SERVICES Memorandum PUBLIC H EALTH S ERVICE Food and Drug Administration