FDA
176 Guidance for Industry Specifications: Test Procedures And Acceptance Criteria For New Veterinary Drug Substances And New Medicinal Products: Chemical Substances VICH GL39 FINAL GUIDANCE Comments and suggestions regarding the document should be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov/. All comments should be identified with the Docket No. 2005D-0199 MoreThe extended application of the concepts in this guidance to other ..... should be capable of distinguishing both enantiomers and the racemic mixture. For a ... Less
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