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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.
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Date created: February 6, 2006 |
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