|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | | FDA Announces Availability of Final Guidance - Development and Submission of Near Infrared Analytical Procedures Today, the Food and Drug Administration is announcing the final guidance for industry entitled "Development and Submission of Near Infrared Analytical Procedures." This guidance will help manufacturers using near infrared (NIR)-based analytical procedures evaluate identity, strength, quality, purity, and potency of drugs. The recommendations in the guidance apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small molecule drugs. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files. FDA intends to issue recommendations specific to NIR methods used for biological products under biologics license applications in a future revision to this guidance. This guidance finalizes the draft guidance issued on March 31, 2015. The final guidance includes updates to reflect agency regulatory experience and technological advancements in the industry, as well as management of NIR procedures over the life cycle of products. This guidance provides information on the following: - Development and submission of NIR analytical procedures used during and for the manufacture and analysis of pharmaceuticals (including raw materials, in-process materials and intermediates, drug substances, and finished products)
- Recommendations to manufacturers for applying the concepts described in the guidance for industry entitled "PAT--A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance" (https://www.fda.gov/media/71012/download) and the International Council for Harmonisation guidance for industry entitled "Q2(R1) Validation of Analytical Procedures: Text and Methodology" (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q2-r1-validation-analytical-procedures-text-and-methodology) to NIR analytical procedures that use chemometric models
- The type of information that should be submitted about NIR analytical procedures in applications.
| | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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