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The Committee is composed of individual members from companies in the pharmaceutical industry, which are involved in the Research and Development of new chemical/biological entities and the manufacturing and marketing of human prescription drugs, which are primarily supported by a New Drug Application (NDA).
Each pharmaceutical company is allowed to have one member and one alternate on the committee. A corporation with more than one company/division with drug and pharmaceuticals as their primary business (whether or not they are independent companies) may assign an alternate from another company/division within the corporation.
Corporations that have multiple independent operating companies are allowed one member per independent operating company providing the company and individual meet the membership requirements. An independent operating company within a corporation is defined as a company that has a separate Marketing, Manufacturing and Package Development/Engineering function from other companies within the corporation. (If a company within a corporation has independent groups for one or two of the listed functions but a combined third group, they are not considered to be an independent company.) It is the responsibility of the Committee to determine if multiple companies from one corporate entity applying for membership meet the requirements. In order to best make this determination, the applying member must provide a company/corporate and department organization chart with their application.
When corporations merge and multiple individuals from the newly combined corporation are members of the Committee and these members are not covered by the rule for independent operating companies for corporations, as described above, it is the responsibility of the corporation to determine which member will remain on the committee. It is possible that one of the members will be primary and the other member will become the alternate. The new combined corporation, if not covered by the rule for independent operating companies for corporations, will be permitted to maintain only one membership (with one alternate).
Only the elected member or his/her alternate can vote on committee matters.
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