Nonprescription
Drugs Advisory Committee (NDAC)
Slides
Presented
The committees will Discussion
Topics: (1) microbiologic surrogate
endpoints used to demonstrate the effectiveness of antiseptic products used in
health care settings (2) related public health issues, (3) trial design issues
and (4) statistical issues.
Issue Overview Susan
Johnson, Pharm.D., Ph.D, Associate
Director [HTML] [PPT] Division
of Over-the-Counter Drug Products
Office of Drug Evaluation V, CDER
Prevention of Surgical Site
Infections Michelle Pearson,
M.D.
[HTML]
[PPT] Chief,
Prevention & Evaluation
Centers
for Disease Control and Prevention
Regulatory History of Healthcare Tia Frazier, R.N., M.S., Regulatory Project
Manager
Antiseptic Drug Products Division of Over-the-Counter Drug
Products
[HTML]
[PPT] Office
of Drug Evaluation V, CDER
Testing of Health Care Michelle Jackson, Ph.D., Microbiologist
Antiseptic Drug Products Division of Over-the-Counter Drug
Products
[HTML]
[PPT] Office
of Drug Evaluation V, CDER
Microbiological Surrogate Endpoints John Powers, M.D., Lead M
in Clinical Trials of Antimicrobial Drug Development and Resistance
Infectious Diseases Initiatives
[HTML]
[PPT] Office
of Drug Evaluation IV, CDER
Antiseptics and Infection John Boyce, M.D.
Control Practice Clinical Professor,
Department of Internal M
[HTML]
[PPT]
The Quest for Clinical Benefit Steven
Osborne, M.D., M
[HTML]
[PPT] Division
of Over-the-Counter Drug Products
Office of Drug Evaluation V, CDER
OTC-TFM Monograph Thamban Valappil, Ph.D., Statistician
Statistical Issues of Study Design Center for Drug Evaluation and
Research
and Analysis Office
of Pharmaceutical Science
[HTML] [PPT] Division
of Biometrics III
Open Public Hearing Speakers
Steven C. Felton, PH.D. [HTML]
[PPT]
M. Khalid Ijaz, D.V.M., Ph.D. [HTML] [PPT]
Industry
Presentation:
The
Value of Surrogate Endpoint George
Fischler,
Testing
for Topical Antimicrobial Manager
Microbiology Research & Development
Products The Dial Corporation
Representing: The Cosmetics, Toiletries and Fragrance
Association (CTFA) and the Soap and Detergent Association (SDA)
Statistical Issues in Study Design James P. Bowman,
Technical
Director and Biostatistician
Hill
Top Research Inc.
Representing: The Cosmetics, Toiletries and Fragrance Association
(CTFA) and the Soap and Detergent Association (SDA)