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Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product - Draft Guidance for Industry and Food and Drug Administration Staff

FDA-PRINCIPLES - 2016 DRAFT - DRAFT
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Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product - Draft Guidance for Industry and Food and Drug Administration Staff


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Document Number

1400027

Revision Level

2016 DRAFT

Status

Draft

Publication Date

July 15, 2016

Page Count

48 pages