Management of the PTCC Nonclinical Biologics Subcommittee

Manual of Policies and Procedures (CDER MaPP) 7400.11 Management of the PTCC Nonclinical Biologics Subcommittee (PDF - 54 KB)

PURPOSE
• This MAPP describes the roles and responsibilities of the Pharmacology/Toxicology Coordinating Committee (PTCC) Nonclinical Biologics Subcommittee (NBS), the structure and function of the subcommittee, the procedures to be used in designating members to serve on the subcommittee and their responsibilities, and the procedures for consult requests of the NBS and responses by NBS to these requests.

open here please:
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM203137.pdf