Advisory Committee for Pharmaceutical Sciences

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Advisory Committee for Pharmaceutical Sciences

• Pharmacology-Toxicology Subcommittee

Frank D. Sistare October 21, 2002
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Process

• PTCC Research Subcommittee identifies topical
  scientific areas to CDERs Pharm-Tox Coordinating
  Committee
• PTCC presents specific issues to ACPS P-T
  Subcommittee
• When decision is made for NCSS to coordinate
  external collaborative research, PTCC dialogs
  with ACPS P-T Subcommittee regarding impact of
  final data conclusions

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ACPS Pharm-Tox Subcommittee Membership

• Chairperson ACPS Member
• Consumer Rep ACPS member
• One is NCTR NCSS Member
• 4 - 6 ad hoc members w selected P/T expertise

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Overview of Advisory System Structure to Optimize
Scientific Support for Evolution of Regulatory
Decision-Making
(SAB)
Key Linkages and Interactions