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Info on Pharmacogenomic Data Guidance Sent to OMB

04/28/2014

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Pharmacogenomic Data Submissions,” has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The guidance provides recommendations to sponsors submitting or holding INDs, NDAs, or BLAs on what pharmacogenomic data should be submitted to the agency during the drug development process. To view this notice, click here.

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