PDA STANDARDS DEVELOPMENT PROGRAM Policies and Procedures

3.3.4.1 Advisory Boards The AB’s responsibilities include the following: a) authorizing the initiation and termination of consensus bodies and consensus body activities; b) advising the consensus body chairs in developing and directing the consensus body's program of work; c) reviewing the progress of consensus body work; d) advising the PDA Board of Directors on the appointment of consensus body. [...] The PDA S&RA staff shall consider the need for the new work, the priority of the work for PDA, the feasibility of completing the work, whether the work is in PDA’s scope, and whether PDA has sufficient resources— including stakeholder participation—to undertake the new work. [...] The appeal shall state the nature of the objection, including the details of the denial of due process rights, the real or potential adverse effects upon the appellant, the actions or inactions at issue, and the specific remedial action that would satisfy the appellant’s concerns. [...] 19 PDA STANDARDS DEVELOPMENT PROGRAM: Policies and Procedures 8.4 Appeal to the PDA Board of Directors 8.4.1 Filing of an appeal to the Board of Directors An appeal to the PDA Board of Directors shall be filed in writing within 15 calendar days of notification of the results of an appeal to the Advisory Board and must explain why the Advisory Board decision should be modified. [...] Work for the net benefit of the We recognize that the development of standards is for the net benefit of pharmaceutical community the pharmaceutical community, over and above the interests of any individual or organization.