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Advisory Committee for Pharmaceutical Science’s

Advisory Committee for Pharmaceutical Science’s. Pharmacology-Toxicology Subcommittee. Robert E. Osterberg October 21, 2002. ACPS Pharm-Tox Subcommittee. Background 1-CDER advisory committees provide CDER with non-binding but highly valuable expert external advice.

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Advisory Committee for Pharmaceutical Science’s

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  1. Advisory Committee for Pharmaceutical Science’s Pharmacology-Toxicology Subcommittee Robert E. Osterberg October 21, 2002

  2. ACPS Pharm-Tox Subcommittee • Background 1-CDER advisory committees provide CDER with non-binding but highly valuable expert external advice. 2-This subcommittee is expected to provide feedback to the PTCC and facilitate NCTR’s NCSS in meeting CDER’s research needs.

  3. ACPS Pharm-Tox Subcommittee • Objectives and Responsibilities To provide expert advisory feedback to the PTCC : a) in targeted cross-cutting areas of pharm-tox where integration of new scientific knowledge or methodology could be helpful in drug development AND

  4. ACPS Pharm-Tox SubcommitteeObjectives/Responsibilities(cont) b) in helping to identify laboratory based research priorities to address data gaps identified by the PTCC. • To provide input to NCTR’s NCSS to address CDER’s identified data gaps. • To advise the PTCC in the evaluation of research data derived from NCSS related to pharm-tox activities.

  5. ACPS Pharm-Tox Subcommittee • Procedures a-Meetings of the P/T Subcommittee of the ACPS will occur prn. b-Two meetings/year are anticipated. • Communications a-Agendas/topics for the ACPS Pharm-Tox Subcommittee will be proposed by the PTCC.

  6. ACPS Pharm-Tox SubcommitteeCommunications (cont) b-Activities/recommendations of the PT Subcommittee of the ACPS will be given to the ACPS, to the CDER PTCC and, as needed, to NCTR’s NCSS. c-A member of the PTCC’s Research Subcommittee will serve on NCTR’s NCSS.

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