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Von Willebrand disease
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101	Summary Basis for Regulatory Action Orphan Designation 22 October 2014 Natalya Ananyeva, PhD, Committee Chairperson Add to Reading List Source URL: www.fda.gov Language: English Coagulation system Medicine Quality Clinical research Factor VIII Verification and validation Validation Von Willebrand disease Coagulation Pharmaceutical industry Blood Validity
102	Summary Basis for Regulatory Action Date: [removed]From: Irwin M. Feuerstein, M.D., M.S., M.B.A., Chair of the BLA BLA/STN#: [removed]Applicant Name: Pfizer Incorporated / Wyeth Biopharma Division of Wyeth Pharmaceu Add to Reading List Source URL: www.fda.gov Language: English Hematology Clinical research Design of experiments Moroctocog alfa Factor VII Clinical trial Desmopressin Von Willebrand disease Drotrecogin alfa Medicine Haemophilia Health
103	HIGHLIGHTS OF PRESCRIBING INFORMATION Add to Reading List Source URL: www.fda.gov Language: English Coagulation system Haemophilia Von Willebrand disease Recombinant proteins Factor VIII Coagulation Von Willebrand factor Desmopressin Willebrand Blood Anatomy Medicine
104	components, including hamster proteins[removed]HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XYNTHA safely and effectively. See full prescribing information for XYN Add to Reading List Source URL: www.fda.gov Language: English Blood Medical equipment Syringe Venipuncture Von Willebrand disease Medicine Haemophilia Health
105	RECOMBINATE [Antihemophilic Factor (Recombinant)] Lyophilized Powder for Reconstitution for injection Reconstitute with 10 mL of Sterile Water for Injection using Baxject II DESCRIPTION Add to Reading List Source URL: www.fda.gov Language: English Anatomy Recombinant proteins Factor VIII Coagulation Factor VII Von Willebrand disease Desmopressin Moroctocog alfa Blood Coagulation system Haemophilia
106	CDER Clinical Review Template Add to Reading List Source URL: www.fda.gov Language: English Blood Coagulation system Peripheral membrane proteins Von Willebrand disease Coagulation Factor IX Bleeding Clinical trial Partial thromboplastin time Haemophilia Medicine Health
107	RECOMBINATE [Antihemophilic Factor (Recombinant)] Lyophilized Powder for Reconstitution for injection Reconstitute with 5 mL of Sterile Water for Injection using Baxject II DESCRIPTION Add to Reading List Source URL: www.fda.gov Language: English Anatomy Recombinant proteins Factor VIII Factor VII Von Willebrand disease Coagulation Desmopressin Moroctocog alfa Blood Coagulation system Haemophilia
108	RECOMBINATE Antihemophilic Factor (Recombinant) Lyophilized Powder for Reconstitution for injection Reconstitute with 5 mL of Sterile Water for Injection using double-ended needles Add to Reading List Source URL: www.fda.gov Language: English Anatomy Recombinant proteins Factor VIII Coagulation Factor VII Von Willebrand disease Desmopressin Moroctocog alfa Blood Coagulation system Haemophilia
109	UDC The Universal Data Collection Program December 2003/Vol.5/No.1 Report on the Universal Data Add to Reading List Source URL: www.cdc.gov Language: English - Date: 2014-02-03 16:21:24 Coagulation system Haemophilia Hematology Viral diseases Von Willebrand disease Von Willebrand factor HIV/AIDS Hepatitis Desmopressin Medicine Blood Health
110	Kogenate FS Package Insert Add to Reading List Source URL: www.fda.gov Language: English Anatomy Recombinant proteins Factor VII Von Willebrand disease Coagulation Blood Coagulation system Haemophilia

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