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Pharmacogenomic Data Submissions Guidance Out

08/29/2007

Federal Register Notice: FDA is making available a draft guidance, Pharmacogenomic Data Submissions — Companion Guidance. The guidance is intended as a companion to a 2005 guidance of the same name and includes experience gained since then with voluntary genomic data submissions as well as with review by FDA of numerous protocols and data submitted under INDs, NDAs, and BLAs. To download the guidance, click here. To view this notice, click here.

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