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GUIDANCE DOCUMENT

Development and Submission of Near Infrared Analytical Procedures March 2015

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2015-D-0868
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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).


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-0868.

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