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2018-07-19
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Field Alert Report Submission: Questions and Answers; Draft Guidance for Industry; Availability
Notices
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D09002ee1c172bda0
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Field Alert Report Submission: Questions and Answers.'' This draft guidance, when finalized, will provide the Agency's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and will outline FDA's recommendations for FAR submissions to help increase their consistency and relevancy. The draft guidance also addresses certain frequently asked questions about FARs.
83 FR 34142
https://www.govinfo.gov/app/details/FR-2018-07-19/2018-15389
2018-15389
fr19jy18-67
4164-01-P
Docket No. FDA-2018-D-2326
https://www.govinfo.gov/app/details/FR-2018-07-19/2018-15389
https://www.govinfo.gov/content/pkg/FR-2018-07-19/html/2018-15389.htm
https://www.govinfo.gov/content/pkg/FR-2018-07-19/pdf/2018-15389.pdf
2 p.
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83 FR 34142
Field Alert Report Submission: Questions and Answers; Draft Guidance for Industry; Availability; Federal Register Vol. 83, Issue
NOTICE
2018-15389
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-09-17
Docket No. FDA-2018-D-2326
4164-01-P
2018-15389
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Field Alert Report Submission: Questions and Answers.'' This draft guidance, when finalized, will provide the Agency's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and will outline FDA's recommendations for FAR submissions to help increase their consistency and relevancy. The draft guidance also addresses certain frequently asked questions about FARs.
Submit either electronic or written comments on the draft guidance by September 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Mamta Gautam-Basak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 2508, Silver Spring, MD 20993-0002, 301- 796-0712; 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; or Rachel Harrington, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4339, Silver Spring, MD 20993-0002, 410- 779-5441.
Guidance:
Field Alert Report Submission: Questions and Answers
,
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
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. 83, no. 139
Office of the Federal Register, National Archives and Records Administration
2018-07-19
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457 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2018-07-19
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https://www.govinfo.gov/content/pkg/FR-2018-07-19/xml/FR-2018-07-19.xml
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FR-2018-07-19
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