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Article: Office of New Drug Chemistry to become 'Office of New Drug Quality Assessment' by April; reviewers to join inspections.(CMC)
- Article from:
- Validation Times
- Article date:
- November 1, 2004
- Author:
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BALTIMORE -- FDA's Office of New Drug Chemistry (ONDC) is being restructured into the Office of New Drug Quality Assessment to facilitate the implementation of the agency's new quality assessment system and to allow reviewers to team up with field investigators on plant audits.
ONDC Director Moheb Nasr, Ph.D., told the American Assn. of Pharmaceutical Scientists (AAPS) annual meeting here Nov. 11 that the name change and official reorganization should take place by April 2005.
"We are breaking down barriers to encourage innovation in industry and in our own house," Nasr said. "There will be a culture change instituted at FDA as part of the transition. We ...