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Surrogate endpoint
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111	Regulatory Basis for U.S. Drug & Biologics Approval Paul G. Kluetz, M.D. Office of Hematology and Oncology Products 1 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Center for Devices and Radiological Health Center for Drug Evaluation and Research Biologic Center for Biologics Evaluation and Research Surrogate endpoint Clinical trial FDA Fast Track Development Program Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
112	Microsoft PowerPoint - Presentation1 Add to Reading List Source URL: www.fda.gov Language: English Diabetic neuropathy Surrogate endpoint Peripheral neuropathy Diabetes management Validity Diabetes Medicine Health
113	Microsoft Word - 0215bsf2.doc Add to Reading List Source URL: www.fda.gov Language: English Health Medical statistics Epidemiology Food and Drug Administration Pharmaceutical industry Surrogate endpoint Clinical trial Pharmaceutical sciences Pharmacology Medicine
114	Microsoft Word - 0215bsf1.doc Add to Reading List Source URL: www.fda.gov Language: English Research Epidemiology Pharmacology Clinical trials Clinical research Surrogate endpoint Food and Drug Administration Health Medical statistics Medicine
115	Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Add to Reading List Source URL: www.fda.gov Language: English Science Pharmacology Design of experiments Epidemiology Medical statistics Surrogate endpoint Clinical trial Placebo-controlled study Food and Drug Administration Clinical research Research Medicine
116	Guidance for Industry ISE Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical research Epidemiology Pharmacology Pharmaceutical industry Surrogate endpoint Center for Biologics Evaluation and Research Clinical trial New Drug Application Medicine Research Health
117	Draft Agenda:[removed]INTERNAL USE ONLY Add to Reading List Source URL: www.fda.gov Language: English Center for Biologics Evaluation and Research Food and Drug Administration Influenza Surrogate endpoint Antivenom Medicine Health Clinical research
118	Transcript: Public Workshop on Minimal Residual Disease (MRD) as a Surrogate Endpoint in Acute Myeloid Leukemia (AML) Add to Reading List Source URL: www.fda.gov Language: English Clinical trials Medical research Medical terms Minimal residual disease Acute myeloid leukemia Surrogate endpoint Medicine Acute leukemia Myeloid leukemia
119	Minimal Residual Disease (MRD) as a Surrogate Endpoint in Acute Myeloid Leukemia (AML) Workshop- March 4, 2013 DISCUSSION POINTS Add to Reading List Source URL: www.fda.gov Language: English Leukemia Minimal residual disease Acute myeloid leukemia Clinical trials Medical terms Surrogate endpoint Biomarker Medicine Acute leukemia Myeloid leukemia
120	Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English Clinical trials Epidemiology Medical research Medical terms Pharmacology Surrogate endpoint Food and Drug Administration Antivenom Center for Biologics Evaluation and Research Medicine Health Clinical research

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