FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Back


2005P-0322
C 1
Volume 2

Comment

Tab 1 - Tercica Press Release (May 2, 2005) Published Material

Tab 2 - Tercica Press Release (June 16, 2004) Published Material

Tab 3 - C. Azcona, et al., Growth Response to rhIGF-I 80 micrograms/kg Twice Daily in Children with Growth Hormone Insensitivity Syndrome: Relationship to Severity of Clinical Phenotype, Clin. Endocrinol. 51: 787-92 (1999) Published Material

Tab 4 - M.B. Ranke, et al., Insulin-Like Growth Factor I Improves Height in Growth Hormone Insensitivity: Two Years’ Results, Hormone Res. 44: 253-64 (1995) Published Material

Tab 5 - J. Guevara-Aguirre, et al., A Randomized, Double Blind, Placebo-Controlled Trial on Safety and Efficacy of Recombinant Human Insulin-Like Growth Factor-Z in Children with Growth Hormone Receptor Deficiency, J. Clin. Endocrinol. Metab. 80: 1393-98 (1995) Published Material

Tab 6 - S.D. Boulware, et al., Comparison of the Metabolic Effects of Recombinant Human Insulin-like Growth Factor-Z and Insulin: Dose-Response Relationships in Healthy Young and Middle-aged Adults, J. Clin. Invest. 93(3): 1131-9 (1994) Published Material

Tab 7 - H.P. Guler, et al., Short-Term Metabolic Effects of Recombinant Human Insulin-Like Growth Factor I in Healthy Adults, N Engl. J. Med. 317(3): 137-40 (1987) Published Material

Tab 8 - S.M. Firth, et al., Impaired Blockade of Insulin-Like Growth Factor I (IGF-I)-Induced Hypoglycemia by IGF Binding Protein-3 Analog with Reduced Ternary Complex-Forming Ability, Endocrinology 143(5): 1669-76 (2002) Published Material

Tab 9 - P.F. Backeljauw, et al., Therapy for 6.5-7.5 Years with Recombinant Insulin-Like Growth Factor I in Children with Growth Hormone Insensitivity Syndrome: A Clinical Research Center Study, J. Clin. Endocrinol. Metab. 86(4): 1504-1510 (2001) Published Material

Tab 10 - P.F. Backeljauw, et al., Prolonged Treatment with Recombinant Insulin-Like Growth Factor-I in Children with Growth Hormone Insensitivity Syndrome - A Clinical Research Center Study, J. Clin. Endocrinol. Metab. 81(9): 3312-7 (1996) Published Material

Tab 11 - S. Malozowski, et al., Growth hormone, insulin-like growth factor I, and benign intracranial hypertension [letter], N. Engl. J. Med. 329(9): 665-666, 666 (Aug. 6, 1993) Published Material

Tab 12 - S. Malozowski and B. Sadel, Risks and benefits of insulin-like growth factor [letter], Ann. Int. Med. 121(7): 549-550, 549 (Oct. 1, 1994) Published Material

Tab 13 - Tercica Press Release (June 6, 2005) Published Material

Tab 14 - H.M. Domene, et al., Deficiency of the Circulating Insulin-like Growth Factor System Associated with Inactivation of the Acid-labile Subunit Gene, N. Engl. J. Med. 350(6): 570-7 (2004) Published Material

Tab 15 - M.J. Abuzzahab, et al., IGF-I Receptor Mutations Resulting in Intrauterine and Postnatal Growth Retardation, N. Engl. J. Med. 349(23): 2211-22 (2003) Published Material

Tab 16 - E.M. Kofoed, et al., Growth hormone insensitivity associated with a STAT5b mutation, N. Engl. J. Med. 349(12): 1139-47 (2003) Published Material

Tab 17 - A.D. Goddard, et al., Mutations of the Growth Hormone Receptor in Children with Idiopathic Short Stature: The Growth Hormone Insensitivity Study Group, N. Engl. J. Med. 333(17): 1093-8 (1995) Published Material

Tab 18 - R.G. Rosenfeld, Insulin-like Growth Factors and the Basis of Growth, N. Engl. J. Med. 349(23): 2184-6 (2003) Published Material

Tab 19 - R.G. Rosenfeld and V. Hwa, Toward a Molecular Basis for Idiopathic Short Stature, J. Clin. Endocrinol. Metab. 89(3): 1066-7 (2004) Published Material

Tab 20 - Z. Laron, The Essential Role of IGF-I: Lessons from the Long-term Study and Treatment of Children and Adults with Laron Syndrome, J. Clin. Endocrinol. Metab. 84(12): 4397-404 (1999) Published Material


Top | Back

Page last updated August 31, 2005 RSChorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management