Pharmacogenomic Data Submissions: Guidance for Industry

Information

Type

Guidance

Regulated products

Biologics, Drugs, Medical Devices

Topics

Administrative / Procedural, Good Clinical Practice (GCP)

Published

March 1, 2005

Last updated

April 27, 2020

Description

This document is a guidance for the industry on pharmacogenomic data submissions, covering administrative and procedural aspects and good clinical practice.

Organization

Country / Region

United States

License

Other (Public Domain)

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