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FDA Resources and tools

FDA website on companion diagnostics: undefinedLINK

 

FDA companion diagnostic guidance: undefinedLINK

 

Workshops co-sponsored by the FDA and AACR

Part I: July 19, 2016

undefinedLINK

 

Part II: October 10, 2017

undefinedLINK

 

cobas® EGFR Mutation Test v2 – SSED

https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150047b.pdf

https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150044b.pdf

 

FDA Draft guidance on principles for codevelopment of an in vitro diagnostic device with a therapeutic product

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Pre-Submission Program Guidance Document

undefinedLINK

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