FDA Guidance for Industry: Development and Submission of Near Infrared Analytical Procedures
Title:
FDA Guidance for Industry: Development and Submission of Near Infrared Analytical Procedures
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM440247.pdf
Content:
This guidance provides recommendations to applicants of new drug applications (NDAs), abbreviated new drug applications (ANDAs) and drug master file (DMF) holders regarding the development and submission of near infrared (NIR) analytical procedures used during the manufacture and analysis of pharmaceuticals (including raw materials, in-process materials and intermediates, and finished products).