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Introduction›SECTION 12. PAPERWORK›• designed to develop a product to treat or prevent a disease or condition; • by conducting pre-clinical activities, clinical trials, or clinical studies, or by carrying out research protocols; and • for the purpose of securing approval of a product under section 505(b) of the Federal Food, Drug, and Cosmetic Act or

section 351(a) of the Public Health Service Act? □ Yes □ No 2. Is the project designed…

Internal Revenue Bulletin 2010-23 · 2026-10-03 edition · updated 2026-10-04 · United States

  1. Is the project designed to determine molecular factors related to diseases or conditions by developing molecular diagnostics

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▸Contents — Internal Revenue Bulletin 2010-23

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