Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling; Availability

A Notice by the Food and Drug Administration on 01/28/2013

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Publication Date:: Monday, January 28, 2013
Agencies:: Department of Health and Human Services; Food and Drug Administration
Dates:: Submit either electronic or written comments on Agency guidances at any time.
Entry Type:: Notice
Action:: Notice.
Document Citation:: 78 FR 5816
Page:: 5816 -5817 (2 pages)
Agency/Docket Number:: Docket No. FDA-2011-D-0082
Document Number:: 2013-01638
Shorter URL:: https://federalregister.gov/a/2013-01638

Regulations.gov Docket Info

Docket Number: FDA-2011-D-0082
Docket Name: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies; Availability
Public Comments: 18 comments

Action

Notice.

Summary

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling.” This guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence variants, could affect a drug's pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety. The guidance provides recommendations on when and how genomic principles should be considered and applied in early-phase clinical studies to address questions arising during drug development and regulatory review.