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2020-08-08
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Drug-Drug Interaction Assessment for Therapeutic Proteins; Draft Guidance for Industry; Availability
Notices
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D09002ee1bdb4888a
United States
Department of Health and Human Services
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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drug-Drug Interaction Assessment for Therapeutic Proteins.'' The purpose of this guidance is to provide a systematic, risk-based approach to help sponsors of investigational new drug applications (INDs) and applicants of biologic license applications (BLAs) determine the need for drug- drug interaction (DDI) studies for a therapeutic protein (TP).
85 FR 48259
https://www.govinfo.gov/app/details/FR-2020-08-10/2020-17412
2020-17412
fr10au20-58
4164-01-P
Docket No. FDA-2020-D-1480
https://www.govinfo.gov/app/details/FR-2020-08-10/2020-17412
https://www.govinfo.gov/content/pkg/FR-2020-08-10/html/2020-17412.htm
https://www.govinfo.gov/content/pkg/FR-2020-08-10/pdf/2020-17412.pdf
3 p.
48259
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85 FR 48259
Drug-Drug Interaction Assessment for Therapeutic Proteins; Draft Guidance for Industry; Availability; Federal Register Vol. 85, Issue
NOTICE
2020-17412
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2020-11-09
Docket No. FDA-2020-D-1480
4164-01-P
2020-17412
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drug-Drug Interaction Assessment for Therapeutic Proteins.'' The purpose of this guidance is to provide a systematic, risk-based approach to help sponsors of investigational new drug applications (INDs) and applicants of biologic license applications (BLAs) determine the need for drug- drug interaction (DDI) studies for a therapeutic protein (TP).
Submit either electronic or written comments on the draft guidance by November 9, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Elimika Pfuma Fletcher, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2162, Silver Spring, MD 20993, 301-796- 3473; 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:
Drug-Drug Interaction Assessment for Therapeutic Proteins,
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
Federal Register
Vol. 85, no. 154
Office of the Federal Register, National Archives and Records Administration
2020-08-10
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396 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2020-08-10
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https://www.govinfo.gov/app/details/FR-2020-08-10
https://www.govinfo.gov/content/pkg/FR-2020-08-10/pdf/FR-2020-08-10.pdf
https://www.govinfo.gov/content/pkg/FR-2020-08-10/xml/FR-2020-08-10.xml
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