Russell Katz

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Issues in clinical trial design from the FDA perspective
    Russell Katz
    Division of Neuropharmacological Drug Products, Center for Drug Evaluation and Research, Office of Drug Evaluation I, Food and Drug Administration, Rockville, Maryland 20852, USA
    Epilepsia 44:9-15. 2003
  2. pmc Biomarkers and surrogate markers: an FDA perspective
    Russell Katz
    Division of Neuropharmacological Drug Products, United States Food and Drug Administration, Rockville, Maryland 20852, USA
    NeuroRx 1:189-95. 2004
  3. pmc FDA: evidentiary standards for drug development and approval
    Russell Katz
    Division of Neuropharmacological Drug Products, United States Food and Drug Administration, Rockville, Maryland 20852, USA
    NeuroRx 1:307-16. 2004
  4. ncbi request reprint Regulatory aspects of vascular dementia in the United States
    Armando Oliva
    Division of Neuropharmacological Drug Products, US Food and Drug Administration, Rockville, MD 20857, USA
    Int Psychogeriatr 15:293-5. 2003
  5. ncbi request reprint FDA update
    Russell Katz
    Epilepsy Res 68:85-94. 2006

Collaborators

  • Armando Oliva
  • Ranjit Mani

Detail Information

Publications5

  1. ncbi request reprint Issues in clinical trial design from the FDA perspective
    Russell Katz
    Division of Neuropharmacological Drug Products, Center for Drug Evaluation and Research, Office of Drug Evaluation I, Food and Drug Administration, Rockville, Maryland 20852, USA
    Epilepsia 44:9-15. 2003
  2. pmc Biomarkers and surrogate markers: an FDA perspective
    Russell Katz
    Division of Neuropharmacological Drug Products, United States Food and Drug Administration, Rockville, Maryland 20852, USA
    NeuroRx 1:189-95. 2004
    ..In this article, the relevant regulatory context will be discussed, as well as the epistemological problems related to the interpretation of clinical trials in which unvalidated surrogate markers are used as primary outcomes...
  3. pmc FDA: evidentiary standards for drug development and approval
    Russell Katz
    Division of Neuropharmacological Drug Products, United States Food and Drug Administration, Rockville, Maryland 20852, USA
    NeuroRx 1:307-16. 2004
    ....
  4. ncbi request reprint Regulatory aspects of vascular dementia in the United States
    Armando Oliva
    Division of Neuropharmacological Drug Products, US Food and Drug Administration, Rockville, MD 20857, USA
    Int Psychogeriatr 15:293-5. 2003
    ..The term "vascular dementia" may not be entirely appropriate to describe this population...
  5. ncbi request reprint FDA update
    Russell Katz
    Epilepsy Res 68:85-94. 2006
    ..FDA is Agency is reviewing analyses describing historical controls...