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U.S. Department of Health and Human Services

About FDA

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Office of Pharmaceutical Science Coordinating Committee (OPS CC)

Office of Pharmaceutical Science Coordinating Committee (OPS CC) serves as a forum for identifying and discussing scientific, technical and regulatory issues that may require OPS to develop and implement applicable policy. The Immediate Office of OPS has authority over OPS CC which has representatives for the three application review offices and the laboratory research office under OPS (Office of Biotechnology Products, Office of Generic Drugs, Office of New Drug Quality Assessment (formerly the Office of New Drug Chemistry) and Office of Testing and Research).

OPS CC was developed in order to streamline the efforts of the previous Chemistry, Manufacturing, and Control (CMC) CC structure. The emphasis is now placed on decision making at the coordinating committee level. Consistency across OPS and less time consuming processes for developing policies are the guiding principles.

Among the first efforts for OPS CC is to synchronize the current guidance documents, both draft and final, with "current thinking" in the Agency. In particular, implementation of the changes recommended by the "Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach" initiative may initiate guidance revision, consolidation, or withdrawal.
 

 

Date created: February 6, 2006