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White paper: Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product

White paper: Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product

2 March, 2017

FDA draft guidance on the Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, published on July 14, 2016, can be viewed as a testament to the Agency's commitment to incorporate scientific advances into its regulatory framework. In the 90 days this "how-to guide" was open for comment some 15 companies and associations responded, including Diaceutics.|FDA draft guidance on the Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, published on July 14, 2016, can be viewed as a testament to the Agency's commitment to incorporate scientific advances into its regulatory framework. In the 90 days this "how-to guide" was open for comment some 15 companies and associations responded, including Diaceutics.

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