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 2014_register executive 2014-02-19 article Notices D09002ee1c7fa6a24 D09002ee1c7fa6a91 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United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Analytical Procedures and Methods Validation for Drugs and Biologics." This revised draft guidance supersedes the 2000 draft guidance for industry on "Analytical Procedures and Methods Validation" and, when finalized, will also replace the 1987 FDA guidance for industry on "Submitting Samples and Analytical Data for Methods Validation." This draft guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. 79 FR 9467 https://www.govinfo.gov/app/details/FR-2014-02-19/2014-03580 2014-03580 fr19fe14-40 4160-01-P Docket No. FDA-2014-D-0103 https://www.govinfo.gov/app/details/FR-2014-02-19/2014-03580 https://www.govinfo.gov/content/pkg/FR-2014-02-19/html/2014-03580.htm https://www.govinfo.gov/content/pkg/FR-2014-02-19/pdf/2014-03580.pdf 2 p. 9467 9468 79 FR 9467 Draft Guidance for Industry on Analytical Procedures and Methods Validation for Drugs and Biologics; Availability; Federal Register Vol. 79, Issue NOTICE 2014-03580 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-D-0103 4160-01-P 2014-03580 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Analytical Procedures and Methods Validation for Drugs and Biologics." This revised draft guidance supersedes the 2000 draft guidance for industry on "Analytical Procedures and Methods Validation" and, when finalized, will also replace the 1987 FDA guidance for industry on "Submitting Samples and Analytical Data for Methods Validation." This draft guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

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 May 20, 2014. Lucinda Buhse, Center for Drug Evaluation and Research, Food and Drug Administration, 1114 Market St., Suite 1002, St. Louis, MO 63101, 314-539-2134; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852- 1448, 301-827-6210. Draft Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 79, no. 33 Office of the Federal Register, National Archives and Records Administration 2014-02-19 continuing daily deposited born digital 249 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-02-19 P0b002ee1873c1a1d 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19fe14 https://www.govinfo.gov/app/details/FR-2014-02-19 https://www.govinfo.gov/content/pkg/FR-2014-02-19/pdf/FR-2014-02-19.pdf https://www.govinfo.gov/content/pkg/FR-2014-02-19/xml/FR-2014-02-19.xml fdlp 9379 9619 DGPO 2014-02-19 2024-06-03 FR-2014-02-19 machine generated eng FR FR-2014-02-19 79 33