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Office of Pharmaceutical Science

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Office of Pharmaceutical Science

Helen N. Winkle, Director
Ajaz S. Hussain, Ph.D., Deputy Director

 

Introduction

The Office of Pharmaceutical Science (OPS) is an integral part of CDER's new and generic drug product application review process.  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. 

OPS coordinates its activities with its sister office, the Office of New Drugs (OND).  The Office of Pharmaceutical Science was created in a 1995 CDER reorganization and has about 500 of CDER's 1,700 employees.  OPS has four main offices:

  • Office of Generic Drugs
  • Office of New Drug Chemistry
  • Office of Clinical Pharmacology and Biopharmaceutics
  • Office of Testing and Research

Staff working in these offices have backgrounds in chemistry, biopharmaceutics, clinical pharmacology, pharmaceutical science, microbiology, pharmacology/toxicology and labeling.

Activities of OPS include:

  • Supporting the review function within the Center for Drug Evaluation and Research (CDER).
  • Promoting the adherence to and development of sound regulatory policy and decision-making.
  • Managing discipline-related Coordinating Committees.
  • Managing the Advisory Committee for Pharmaceutical Science.
  • Managing the information technology infrastructure and initiatives that support the review process.

OPS facilitates the linking of laboratory research to regulatory practice by working closely with CDER Coordinating Committees.  OPS gives the Coordinating Committees research findings to assist in the Committees' review of important regulatory issues.  These committees develop new guidances and regulations, and implement initiatives from the International Conference on Harmonisation (ICH).  

OPS provides scientific and regulatory support by:

  • Developing and implementing review management and scientific policies pertaining to the new drug review process for chemistry, manufacturing controls, clinical pharmacology and biopharmaceutics.
  • Evaluating and approving abbreviated new drug application (ANDAs) and their amendments.
  • Developing and implementing policies and programs through applied regulatory research working with groups inside and outside FDA. 
  • Performing drug testing and scientific evaluation of drug products in support of the regulatory components of FDA.
  • Developing and implementing standards and policies for both generic drugs and new drugs that enhance the drug development and regulatory review process.
  • Providing scientific oversight, through the Center's Office of New Drug Chemistry, of chemistry and manufacturing controls (CMC) and the sterility sections of Investigational New Drugs, New Drug Applications, and supplements.
  • Validating the comparability of clinical safety and efficacy studies conducted during the IND phase of drug development, and evaluating the impact of drug-to-drug interactions and population characteristics on the safety and efficacy of drug products.

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Office of Pharmaceutical Science Organization

The  OPS organization chart shows the divisions within each Office.

Office of Pharmaceutical Science Initiatives

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Office of Pharmaceutical Science Activities

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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 David Holovac, holovacd@cder.fda.gov with feedback about this site.


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FDA/Center for Drug Evaluation and Research
Last Updated: December 11, 2003
Originator: OTCOM/DLIS
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