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Biomarker Development Will Get Advisory Committee Review

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA will seek advisory committee reviews of pharmacogenomic biomarkers as part of their development process

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Pharmacogenomics' Next Step: Public Workshop In April

After releasing a final guidance for industry data submissions, FDA continues to seek input on additional pharmacogenomic guidances. The agency will release a concept paper on co-development of drugs and diagnostics for the April 11-13 workshop.

Pharmacogenomics' Next Step: Public Workshop In April

After releasing a final guidance for industry data submissions, FDA continues to seek input on additional pharmacogenomic guidances. The agency will release a concept paper on co-development of drugs and diagnostics for the April 11-13 workshop.

Pharmacogenomics Advisory Committee Being Formed By FDA To Oversee Data Submissions

The agency expects to publish final pharmacogenomics guidance this summer, along with "companion documents" on the interdisciplinary PG review group and a standard process for voluntary PG data submissions, FDA's Lesko tells DIA EuroMeeting in Prague.

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