Other Laboratory Operations
Food and Drug Administration
The goal is to satisfy the need for regulatory analytical methods meeting current and anticipated public health program needs and agency priorities. This Laboratory Manual section provides the procedures for the identification, development, submission, review and publication of method protocols, validation studies, method extensions or other research studies. The procedures a ssure that projects meet regulatory needs, accomplish their intended purpose, include validation for Agency-wide distribution (where appropriate and/or in conjunction with the Office of Foods), and become meaningful analytical tools for use. Additionally it provides scientific conduct guidelines for the program and encourages and enhances the creative skills of talented scientists in ORA Laboratories.