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U.S. Department of Health and Human Services

Science & Research

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Volume III - 6.1 Introduction

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-06

VERSION NO.:2.7

Section 6 ORA Method Development and Validation Program

EFFECTIVE DATE:
04-02-04
REVISED: 01-09-14

As the regulatory agency designated to maintain the safety of the nation's foods, drugs, biologics, medical devices, and radiological products, FDA has broad responsibilities to protect the public health. It is the vision of the Office of Regulatory Science (ORS) to provide a convincing and prevailing scientific, research and analytical base for regulatory decisions that protect and promote public health. Vital to carrying out this vision is the continual development, validation and improvement of methods that support our regulatory responsibilities. The FDA Office of Foods Guidelines for Method Validation in Foods and the ORA Method Development and Validation Program is designed to satisfy the need for regulatory analytical methods meeting current and anticipated public health program needs and agency priorities. The exploration of new technologies and methods for rapid analyses, as well as hypothesis driven basic studies, are also important components of this science program.