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FDADocs 5/9/2008 | 0 (0) | 27 | 0 | 0 | English
ABBOTT PRISM?? HBcore Summary Basis for ApprovalProduct Trade Name Proper Name Applicant ABBOTT PRISM??? HBcore Hepatitis B Virus Core Antigen (E. coli, Recombinant) Abbott Laboratories Dept. 49C ... more>>
FDADocs 5/9/2008 | 0 (0) | 12 | 0 | 0 | English
.1.5 Summary of Basis for ApprovalCOBAS AmpliScreen??? HIV-1 Test, v1.5 Summary of Basis for ApprovalDecember 20, 2002 BLA 125059/0Summary of Basis for Approval Page iRoche Molecular ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 12 | 0 | 0 | English
approach to addressing medicines that are marketed without required FDA approval. Second, in a related...Questions and Answers about Unapproved Drugs and FDA???s Enforcement Action Against Carbinoxamine ... more>>
FDADocs 5/9/2008 | 0 (0) | 20 | 0 | 0 | English
Question PosedIs any other response besides complete remission (CR) acceptable as an endpoint for either full or accelerated approval of a new agent in the treatment of acute leukemia (AML or ALL ... more>>
ProfessionalDocument 8/19/2008 | 0 (0) | 18 | 0 | 0 | English
RequestersFOOD AND DRUG ADMINISTRATION Approval and Oversight of the Drug MifeprexGAO... congressional requestersAccountability Integrity ReliabilityApproval and Oversight of the Drug ... more>>
FDADocs 5/5/2008 | 0 (0) | 21 | 0 | 0 | English
SUMMARY BASIS FOR APPROVAL Submission Tracking Number: Biological Product Name: Manufacturer: 125010/0.0Fibrin Sealant (Human) OMRIX biopharmaceuticals Ltd., MDA Blood Bank, Sheba Hospital, POB ... more>>
FDADocs 5/9/2008 | 0 (0) | 21 | 0 | 0 | English
DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health ServiceFood and Drug Administration Rockville, MD 20857NDA 20-414Commanding General U.S. Army Medical Research an... ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 30 | 0 | 0 | English
SUMMARYOF BASISFOR APPROVALProper Name:Hepatitis C Virus Encoded Antigen... 3.0 SIA Summary of Basis for Approval February, 1999TABLE OF CONTENTS SECTION I. II. III ... more>>
FDADocs 5/9/2008 | 0 (0) | 19 | 0 | 0 | English
Summary Basis of ApprovalCalifornia Department of Health Services Botulism Immune Globulin Intravenous (Human) (BIG-IV) Biologics License ApplicationSUMMARY BASIS OF APPROVAL Botulism Immune ... more>>
FDADocs 5/5/2008 | 0 (0) | 29 | 1 | 0 | English
SUMMARY BASIS FOR APPROVALReference Numbers: Biological Product Name: Manufacturer: 87-0508 and 87-0509 Fibrin Sealant 6sterreichisches Institut Fiir Haemoderivate Subsidiary of IMMUNO AG (QIH ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 25 | 0 | 0 | English
Centeon Pharma GmbH Humate-Pa, Antihemophilic Factor (Human) New Indication: von Willebrand diseaseSummary Basis for ApprovalReference Number: Drug Licensed Name:sPLA ... more>>
FDADocs 5/5/2008 | 0 (0) | 17 | 1 | 0 | English
SUMMARY OF BASIS FOR APPROVALReference No.: 103868 (STN) Product Name: NGI UltraQual??? HCV RT...) Polymerase Chain Reaction (PCR) assay, when used in combination with FDA approved pooling and resolution ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 71 | 1 | 0 | English
SUMMARY FOR BASIS OF APPROVALREFERENCENUMBER:92-0308TRADE NAME:TICE@ BCG... 27112DATE OF APPROVAL:August 4, 1998INDICATIONS lntravesicalAND USAGE Use for Carcinoma ... more>>
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