Office of Antimicrobial Products (OAP)
The Office of Antimicrobial Products is responsible for protecting the public health by assuring safe and effective drugs are available to the U.S. population for antimicrobials products (including antibacterial, antimycobacterial, antifungal, antiviral, and antiparasitic products), ophthalmology products, and products for the prevention of rejection in solid organ transplant recipients.
Director: Edward M. Cox, M.D., MPH
Deputy Director: John Farley, M.D., MPH
Associate Director for Regulatory Affairs: Katherine Schuman
Associate Director for Research: Thushi Amini, Ph.D.
Associate Director for Regulatory Science: Sunita Shukla, Ph.D., M.P.H.
Division of Anti-Infective Products (DAIP)
Director: Sumathi Nambiar, M.D., M.P.H.
Deputy Director: Dmitri Iarikov, M.D., Ph.D.
Division of Antiviral Products (DAVP)
Director: Debra Birnkrant, M.D.
Deputy Director: Jeffery Murray, M.D., M.P.H
Division of Transplant and Ophthalmology Products (DTOP)
Director: Ozlem Belen, M.D (Acting)
Deputy Director: Wiley Chambers, M.D.
Overview of research needs, requests for information (RFIs), public workshops/meetings, opportunities for collaboration, externally awarded research studies, and other important research.
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Antimicrobial Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-1300
Fax: (301) 796-9887
- OAP Regulatory Science Activities
- Regulators in EU, Japan and US Take Steps to Converge on Approaches to Development of New Antibacterial Drugs
- FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria
- Antimicrobial Resistance Information for Consumers and Health Professionals
- Tropical Disease Priority Review Voucher Program
- Office of Antimicrobial Products Research Activities
- February 2018 HHS Report to Congress on Generating Antibiotic Incentives Now (GAIN)