ODE Executive Secretary Guidance Manual G87-3
This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.
General Program Memorandum G87-3
August 7, 1987 ODE Executive Secretary Guidance Manual The ODE Executive Secretary Guidance Manual has been developed by this office to provide Executive Secretaries of ODE advisory panels with a convenient reference source of information concerning the rules and procedures governing advisory panels and the responsibilities of Executive Secretaries of these panels. The Manual includes a copy of the "FDA PUBLIC ADVISORY COMMITTEES," A Handbook for Committee Members and Executive Secretaries (OCtober, 1984), and selected Center supplements to the Handbook. The individual Executive Secretary Advisories (ESAs) are intended to augment the information in the Handbook as well as the regulations governing advisory committees (21 CFR Part 14). In addition, the ESAs convey guidance, suggestions, or information which will be useful to Executive Secretaries in ensuring that regulatory and procedural requirements are met in an efficient and consistent manner. The ESAs describe policies and procedures that have been developed over many years of panel administration; thus, they are effective immediately. I recognize, however, that panel administration is very complex and that present ESAs may need refinement or additional ESAs may be required. Executive Secretaries have been encouraged to share their experiences with their colleagues and with me, and I have solicited their suggestions for additional ESAs. Center staff are encouraged to discuss matters pertaining to a particular panel with the Executive Secretary of that panel or with Roger W. Barnes, the ODE focus point for matters involving panel policies, procedures or administration.