FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration U.S. Food and Drug Administration Center for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
Powered by Google

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.


Director's Corner

Presentations on OPS missions and initiatives are compiled.


Interactive Forum between FDA and Generic Industry [PDF] 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.     

Regulatory Information

How to Contact Us

We ask you to take time to communicate with CDER about this web site.  What information is and isn't useful to you? Are there any additional items or categories of information you would like us to add? Please e-mail Jon Clark, jon.clark@fda.hhs.gov  with feedback about this site.

Back to Top     Back to Offices

PDF requires the free Adobe Acrobat Reader

Date created: February 6, 2006, updated April 9, 2008

horizonal rule