Office of Pharmaceutical Science (OPS)
Helen N. Winkle, Director
Keith O. Webber, Ph.D. Deputy Director
Who We Are:
OPS Organization Chart
The Office of Pharmaceutical Science (OPS) is an umbrella organization over the activities of chemistry manufacturing and controls (CMC) review in CDER. This includes assessment of product and process design, evaluation of product quality in light of established standards and setting and maintaining new quality standards.
OPS is an integral part of CDER's new and generic drug product application review process. Staff working in these groups have backgrounds in chemistry, biology, biopharmaceutics, clinical pharmacology, immunology, pharmaceutical science, microbiology, pharmacology/toxicology and labeling.
The goal of OPS is to help establish common approaches to the manufacture and formulation of drugs among pharmaceutical manufacturers. OPS contributes to assuring the quality of drug products by providing uniform policies and review processes for the entire pharmaceutical industry through:
OPS engages in scientific research to support decision making for application review, standard setting and for technology development.
Presentations on OPS missions and initiatives are compiled.
Interactive Forum between FDA and Generic Industry [PDF]
The forum will provide tools to have effective communication between FDA and industry. Industry will learn of common deficiencies in abbreviated new drug applications (ANDA) and impacts of recently passed laws on FDA decisions.
How to Contact Us
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Date created: February 6, 2006, updated April 9, 2008