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 2021_register executive 2021-05-21 article Notices D09002ee1c7b1dc5f D09002ee1c7b1dd48 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Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products." The draft guidance, when finalized, will represent the current thinking of FDA on adjusting for covariates in randomized clinical trials for drugs and biologics. This draft guidance revises the draft guidance "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes" that published April 25, 2019. This revision provides more detailed recommendations for the use of linear models for covariate adjustment and also includes recommendations for covariate adjustment using nonlinear models. 86 FR 27627 https://www.govinfo.gov/app/details/FR-2021-05-21/2021-10760 2021-10760 fr21my21-67 4164-01-P Docket No. FDA-2019-D-0934 https://www.govinfo.gov/app/details/FR-2021-05-21/2021-10760 https://www.govinfo.gov/content/pkg/FR-2021-05-21/html/2021-10760.htm https://www.govinfo.gov/content/pkg/FR-2021-05-21/pdf/2021-10760.pdf 3 p. 27627 27629 86 FR 27627 Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products; Draft Guidance for Industry; Availability; Federal Register Vol. 86, Issue NOTICE 2021-10760 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2021-07-20 Docket No. FDA-2019-D-0934 4164-01-P 2021-10760 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products." The draft guidance, when finalized, will represent the current thinking of FDA on adjusting for covariates in randomized clinical trials for drugs and biologics. This draft guidance revises the draft guidance "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes" that published April 25, 2019. This revision provides more detailed recommendations for the use of linear models for covariate adjustment and also includes recommendations for covariate adjustment using nonlinear models.

Submit either electronic or written comments on the draft guidance by July 20, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Scott N. Goldie, Center for Drug Evaluation and Research, Office of Biostatistics, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993-0002, 301-796-2055, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Guidance: Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products, https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073137.pdf https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 86, no. 97 Office of the Federal Register, National Archives and Records Administration 2021-05-21 continuing daily deposited born digital 301 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2021-05-21 P0b002ee1ae340ef4 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21my21 https://www.govinfo.gov/app/details/FR-2021-05-21 https://www.govinfo.gov/content/pkg/FR-2021-05-21/pdf/FR-2021-05-21.pdf https://www.govinfo.gov/content/pkg/FR-2021-05-21/xml/FR-2021-05-21.xml fdlp 27505 27796 DGPO 2021-05-21 2024-05-30 FR-2021-05-21 machine generated eng FR FR-2021-05-21 86 97