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2017-12-13
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Refuse To File: New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Availability
Notices
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D09002ee1bdba7211
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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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Refuse to File: NDA and BLA Submissions to CDER.'' The purpose of this guidance is to clarify certain circumstances under which FDA's Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA, or a biologics license application (BLA) or supplemental BLA submitted to CDER, and to underscore the importance of submitting a complete application to minimize the chance of a refuse- to-file (RTF) action by FDA.
82 FR 58615
https://www.govinfo.gov/app/details/FR-2017-12-13/2017-26791
2017-26791
fr13de17-57
4164-01-P
Docket No. FDA-2017-D-6554
https://www.govinfo.gov/app/details/FR-2017-12-13/2017-26791
https://www.govinfo.gov/content/pkg/FR-2017-12-13/html/2017-26791.htm
https://www.govinfo.gov/content/pkg/FR-2017-12-13/pdf/2017-26791.pdf
3 p.
58615
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82 FR 58615
Refuse To File: New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Availability; Federal Register Vol. 82, Issue
NOTICE
2017-26791
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-02-12
Docket No. FDA-2017-D-6554
4164-01-P
2017-26791
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Refuse to File: NDA and BLA Submissions to CDER.'' The purpose of this guidance is to clarify certain circumstances under which FDA's Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA, or a biologics license application (BLA) or supplemental BLA submitted to CDER, and to underscore the importance of submitting a complete application to minimize the chance of a refuse- to-file (RTF) action by FDA.
Submit either electronic or written comments on the draft guidance by February 12, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301- 796-0700.
Guidance:
Refuse to FileNew Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research
,
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 82, no. 238
Office of the Federal Register, National Archives and Records Administration
2017-12-13
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181 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2017-12-13
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https://www.govinfo.gov/app/details/FR-2017-12-13
https://www.govinfo.gov/content/pkg/FR-2017-12-13/pdf/FR-2017-12-13.pdf
https://www.govinfo.gov/content/pkg/FR-2017-12-13/xml/FR-2017-12-13.xml
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