OMB control number
Guidance for Industry - Pharmacogenomic Data Submissions
OMB 0910-0557 · HHS/FDA.
OMB 0910-0557
The information collection supports agency guidance. Respondents to the collections are sponsors holding Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applicatons (BLAs). The guidance makes recommendations to respondents with regarding what pharmacogenomic data to submit to FDA during the drug development process, the format of submissions, and how the data will be used in regulatory decisionmaking.
The latest form for Guidance for Industry - Pharmacogenomic Data Submissions expires 2020-09-30 and can be found here.
Latest Forms, Documents, and Supporting Material
Document Name |
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Voluntary Genomic Data Submissions All Historical Document Collections
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Approved without change |
Extension without change of a currently approved collection | 2017-07-18 | |
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Approved without change |
Extension without change of a currently approved collection | 2014-05-08 | |
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Approved without change |
Extension without change of a currently approved collection | 2011-02-22 | |
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Approved without change |
Extension without change of a currently approved collection | 2007-12-19 | |
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Approved with change |
New collection (Request for a new OMB Control Number) | 2004-09-27 |