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APPENDIX C ALLOWABLE AND EXCLUDED COSTS FOR THE PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS The FD&C Act as amended defines the “process for the review of human drug applications” and the costs that may be incl
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analytical tools / scientific equipment / adverse event data-collection systems / diagnostic biologic products / human drug applications / information technology systems / pre-launch advertising / extract products / covered biological products / volume parenteral drug products / /

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FDA / /

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information technology / /

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