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2019-10-19
article
Drug Master Files; Draft Guidance for Industry; Availability
Notices
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D09002ee1c1213a06
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drug Master Files.'' Once finalized, this guidance will provide FDA's current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs are submitted solely at the discretion of their holders and are not required by statute or regulation. This draft guidance, when finalized, will revise the guidance for industry ``Drug Master Files: Guidelines'' that published in September 1989.
84 FR 56194
https://www.govinfo.gov/app/details/FR-2019-10-21/2019-22821
2019-22821
fr21oc19-48
4164-01-P
Docket No. FDA-2019-D-3989
https://www.govinfo.gov/app/details/FR-2019-10-21/2019-22821
https://www.govinfo.gov/content/pkg/FR-2019-10-21/html/2019-22821.htm
https://www.govinfo.gov/content/pkg/FR-2019-10-21/pdf/2019-22821.pdf
2 p.
56194
56195
84 FR 56194
Drug Master Files; Draft Guidance for Industry; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-22821
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-12-20
Docket No. FDA-2019-D-3989
4164-01-P
2019-22821
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drug Master Files.'' Once finalized, this guidance will provide FDA's current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs are submitted solely at the discretion of their holders and are not required by statute or regulation. This draft guidance, when finalized, will revise the guidance for industry ``Drug Master Files: Guidelines'' that published in September 1989.
Submit either electronic or written comments on the draft guidance by December 20, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Rick Ensor, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6652, Silver Spring, MD 20993-0002, 240-402-2733, 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 Master Files
,
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/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. 84, no. 203
Office of the Federal Register, National Archives and Records Administration
2019-10-21
continuing
daily
deposited
born digital
280 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-10-21
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0042-1219
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https://www.govinfo.gov/app/details/FR-2019-10-21
https://www.govinfo.gov/content/pkg/FR-2019-10-21/pdf/FR-2019-10-21.pdf
https://www.govinfo.gov/content/pkg/FR-2019-10-21/xml/FR-2019-10-21.xml
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FR-2019-10-21
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