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2010-09-24
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Plans to Develop Guidance on Submitting an Archival Copy of an ANDA in Electronic Format; Request for Comments
Notices
D09002ee1bdfb5d1f
D09002ee1bdfb5d8c
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's (FDA's) Office of Generic Drugs (OGD), within its Center for Drug Evaluation and Research, is announcing plans to develop guidance on submitting an archival copy of a complete abbreviated new drug application (ANDA) in electronic format. OGD has encouraged the electronic submission of some types of data on a voluntary basis since 1997. However, these submissions are not archivable and are made in addition to a complete paper submission. OGD plans to expand its electronic data submission program to include all parts of the ANDA, so that the archivable electronic submission can replace the paper submission as the ANDA of record. OGD is soliciting comments from the public on its current program so it can consider these comments as it develops guidance for industry on the submission of complete, archivable ANDA's in electronic format. A draft guidance will be developed and made available for public comment. The ANDA electronic submission guidance will be one in a series of guidances the agency is developing to enable sponsors to submit archivable regulatory submissions in electronic format.
65 FR 4436
https://www.govinfo.gov/app/details/FR-2000-01-27/00-1869
00-1869
fr27ja00-61
4160-01-F
Docket No. 99D-5333
https://www.govinfo.gov/app/details/FR-2000-01-27/00-1869
https://www.govinfo.gov/content/pkg/FR-2000-01-27/html/00-1869.htm
https://www.govinfo.gov/content/pkg/FR-2000-01-27/pdf/00-1869.pdf
2 p.
4436
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65 FR 4436
Plans to Develop Guidance on Submitting an Archival Copy of an ANDA in Electronic Format; Request for Comments; Federal Register Vol. 65, Issue
NOTICE
00-1869
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2000-03-27
Docket No. 99D-5333
4160-01-F
00-1869
Notice.
The Food and Drug Administration's (FDA's) Office of Generic Drugs (OGD), within its Center for Drug Evaluation and Research, is announcing plans to develop guidance on submitting an archival copy of a complete abbreviated new drug application (ANDA) in electronic format. OGD has encouraged the electronic submission of some types of data on a voluntary basis since 1997. However, these submissions are not archivable and are made in addition to a complete paper submission. OGD plans to expand its electronic data submission program to include all parts of the ANDA, so that the archivable electronic submission can replace the paper submission as the ANDA of record. OGD is soliciting comments from the public on its current program so it can consider these comments as it develops guidance for industry on the submission of complete, archivable ANDA's in electronic format. A draft guidance will be developed and made available for public comment. The ANDA electronic submission guidance will be one in a series of guidances the agency is developing to enable sponsors to submit archivable regulatory submissions in electronic format.
Submit written comments by March 27, 2000. General comments are welcome at any time.
Jonathan D. Cook, Center for Drug Evaluation and Research (HFA-358), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5683.
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/cder/OGD
Federal Register
Vol. 65, no. 18
Office of the Federal Register, National Archives and Records Administration
2000-01-27
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178 p.
Table of Contents:
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2010-09-24
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