CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
Nonprescription
Drugs Advisory Committee (NDAC)
Hilton Hotel - The Ballrooms
AGENDA
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.
Conflict
of Interest Statement
Acting
Executive Secretary
Nonprescription
Drugs Advisory Committee
Division of Over-the-Counter
Drug Products
Office of Drug
Evaluation V, CDER
Chief, Prevention &
Evaluation
Centers for Disease Control
and Prevention
Antiseptic Drug Products Division
of Over-the-Counter Drug Products
Office
of Drug Evaluation V, CDER
Antiseptic
Drug Products Division
of Over-the-Counter Drug Products
Office
of Drug Evaluation V, CDER
in Clinical Trials of
Infectious Diseases Antimicrobial Drug Development and
Resistance Initiatives
Office
of Drug Evaluation IV, CDER
Control Practice Clinical
Professor, Department of Internal M
FOOD AND DRUG
ADMINISTRATION
CENTER FOR
DRUG EVALUATION AND RESEARCH (CDER)
Nonprescription Drugs Advisory Committee (NDAC)
AGENDA (Continued)
Division
of Over-the-Counter Drug Products
Office of Drug
Evaluation V, CDER
Statistical
Issues of Study Design Thamban
Valappil, Ph.D., Statistician
and
Analysis Center
for Drug Evaluation and Research
Office
of Pharmaceutical Science
Division
of Biometrics III
Committee
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)