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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

Authors

Jordan Clark

Chief Commercial Officer​

Amit Kumar Jain

Managing Director, Head of Strategy & Corporate Development

FDA draft guidance on the Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, published on July 14, 2016, can be viewed as a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days this "how-to guide" was open for comment some 15 companies and associations responded, including Diaceutics.|FDA draft guidance on the Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, published on July 14, 2016, can be viewed as a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.

About Diaceutics

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX - the world’s first Network solution for the development and commercialization of precision medicine diagnostics. 

Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries.

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