United States Government Publishing Office
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2019_register
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2019-11-30
article
Adaptive Designs for Clinical Trials of Drugs and Biologics; Guidance for Industry; Availability
Notices
D09002ee1bdb68f2d
D09002ee1bdb68f96
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics.'' This guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biological product. The guidance describes important principles for designing, conducting, and reporting the results from an adaptive clinical trial. This guidance finalizes the draft guidance entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics'' issued in October 2018. FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
84 FR 65983
https://www.govinfo.gov/app/details/FR-2019-12-02/2019-25986
2019-25986
fr02de19-35
4164-01-P
Docket No. FDA-2018-D-3124
https://www.govinfo.gov/app/details/FR-2019-12-02/2019-25986
https://www.govinfo.gov/content/pkg/FR-2019-12-02/html/2019-25986.htm
https://www.govinfo.gov/content/pkg/FR-2019-12-02/pdf/2019-25986.pdf
3 p.
65983
65985
84 FR 65983
Adaptive Designs for Clinical Trials of Drugs and Biologics; Guidance for Industry; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-25986
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2020-01-02
Docket No. FDA-2018-D-3124
4164-01-P
2019-25986
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics.'' This guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biological product. The guidance describes important principles for designing, conducting, and reporting the results from an adaptive clinical trial. This guidance finalizes the draft guidance entitled ``Adaptive Designs for Clinical Trials of Drugs and Biologics'' issued in October 2018. FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
The announcement of the guidance is published in the Federal Register on December 2, 2019. Submit either electronic or written comments on the collection of information by January 2, 2020.
Regarding the guidance: Scott Goldie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993- 0002, 301-794-2055; 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:
Adaptive Designs for Clinical Trials of Drugs and Biologics
,
oira_submission@omb.eop.gov
PRAStaff@fda.hhs.gov
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 231
Office of the Federal Register, National Archives and Records Administration
2019-12-02
continuing
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165 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-12-02
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https://www.govinfo.gov/content/pkg/FR-2019-12-02/pdf/FR-2019-12-02.pdf
https://www.govinfo.gov/content/pkg/FR-2019-12-02/xml/FR-2019-12-02.xml
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