The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry Pharmacogenomic Data Submissions

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079849.pdf

Document Type:
Guidance for Industry
Content:
Pharmacogenomic Data Submissions of INDs

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