United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2015-03-31 article Notices D09002ee1c7f7c450 D09002ee1c7f7c4c0 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Development and Submission of Near Infrared Analytical Procedures." This draft guidance provides recommendations to applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the development and submission of near infrared (NIR) analytical procedures used during the manufacture and analysis of pharmaceuticals. This draft guidance only pertains to the development and validation of NIR analytical procedures and does not provide recommendations concerning the set up and qualification of NIR instruments or their maintenance and calibration. 80 FR 17057 https://www.govinfo.gov/app/details/FR-2015-03-31/2015-07266 2015-07266 fr31mr15-61 4164-01-P Docket No. FDA-2015-D-0868 https://www.govinfo.gov/app/details/FR-2015-03-31/2015-07266 https://www.govinfo.gov/content/pkg/FR-2015-03-31/html/2015-07266.htm https://www.govinfo.gov/content/pkg/FR-2015-03-31/pdf/2015-07266.pdf 2 p. 17057 17058 80 FR 17057 Development and Submission of Near Infrared Analytical Procedures; Draft Guidance for Industry; Availability; Federal Register Vol. 80, Issue NOTICE 2015-07266 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2015-D-0868 4164-01-P 2015-07266 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Development and Submission of Near Infrared Analytical Procedures." This draft guidance provides recommendations to applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the development and submission of near infrared (NIR) analytical procedures used during the manufacture and analysis of pharmaceuticals. This draft guidance only pertains to the development and validation of NIR analytical procedures and does not provide recommendations concerning the set up and qualification of NIR instruments or their maintenance and calibration.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 1, 2015. John L. Smith, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1757. Guidance: Development and Submission of Near Infrared Analytical Procedures , http://www.fda.gov/downloads/Drugs/Guidances/ucm070305.pdf http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm265700.htm http://www.regulations.gov Vol. 80, no. 61 Office of the Federal Register, National Archives and Records Administration 2015-03-31 continuing daily deposited born digital 357 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-03-31 P0b002ee18be9e08b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr31mr15 https://www.govinfo.gov/app/details/FR-2015-03-31 https://www.govinfo.gov/content/pkg/FR-2015-03-31/pdf/FR-2015-03-31.pdf https://www.govinfo.gov/content/pkg/FR-2015-03-31/xml/FR-2015-03-31.xml fdlp 16961 17305 DGPO 2015-03-31 2024-06-02 FR-2015-03-31 machine generated eng FR FR-2015-03-31 80 61