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. (acting)
- Division of Anti-Infective Products (DAIP)
- Division of Transplant and Ophthalmology Products (DTOP)
- Division of Antiviral Products (DAVP)
Overview of research needs, requests for information (RFIs), public workshops/meetings, opportunities for collaboration, notable guidances related to regulatory science, externally awarded research studies, and other important regulatory science and research activities.
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
Realignment of the Office of Antimicrobial Products within the Office of New Drugs Antibacterial and Antifungal Product Labeling: Microbiology Susceptibility Interpretive Criteria (Breakpoints) and Quality Control Parameter Updates Antimicrobial Resistance Information for Consumers and Health Professionals Tropical Disease Priority Review Voucher Program Office of Antimicrobial Products Research