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2010-09-24
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Guidance for Industry: Changes To An Approved Application: Biological Products; Availability
Notices
D09002ee1be0191b6
D09002ee1be019244
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) is announcing the availability of a guidance document entitled, ``Guidance for Industry: Changes To An Approved Application: Biological Products.'' The guidance document is intended to assist manufacturers in determining which reporting mechanism is appropriate for a change to an approved application, to reduce the burden on manufacturers of reporting changes, and to facilitate the approval process. The guidance document applies to all licensed biological products and establishments, including Whole Blood, blood components, Source Plasma, and Source Leukocytes, but not including specified biotechnology and specified synthetic biological products, or products formerly referred to as well-characterized therapeutic recombinant DNA-derived and monoclonal antibody biotechnology products. The guidance document announced in this notice revises the draft guidance entitled, ``Changes To An Approved Application; Draft Guidance,'' announced in the Federal Register of January 29, 1996 (61 FR 2749).
62 FR 39904
https://www.govinfo.gov/app/details/FR-1997-07-24/97-19412
97-19412
fr24jy97-138
4160-01-F
Docket No. 95D-0052
https://www.govinfo.gov/app/details/FR-1997-07-24/97-19412
https://www.govinfo.gov/content/pkg/FR-1997-07-24/html/97-19412.htm
https://www.govinfo.gov/content/pkg/FR-1997-07-24/pdf/97-19412.pdf
3 p.
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62 FR 39904
Guidance for Industry: Changes To An Approved Application: Biological Products; Availability; Federal Register Vol. 62, Issue
NOTICE
97-19412
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 95D-0052
4160-01-F
97-19412
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled, ``Guidance for Industry: Changes To An Approved Application: Biological Products.'' The guidance document is intended to assist manufacturers in determining which reporting mechanism is appropriate for a change to an approved application, to reduce the burden on manufacturers of reporting changes, and to facilitate the approval process. The guidance document applies to all licensed biological products and establishments, including Whole Blood, blood components, Source Plasma, and Source Leukocytes, but not including specified biotechnology and specified synthetic biological products, or products formerly referred to as well-characterized therapeutic recombinant DNA-derived and monoclonal antibody biotechnology products. The guidance document announced in this notice revises the draft guidance entitled, ``Changes To An Approved Application; Draft Guidance,'' announced in the Federal Register of January 29, 1996 (61 FR 2749).
Written comments may be submitted at any time.
Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-630), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594- 3074.
Federal Register
Vol. 62, no. 142
Office of the Federal Register, National Archives and Records Administration
1997-07-24
continuing
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182 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-1997-07-24
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https://www.govinfo.gov/app/details/FR-1997-07-24
https://www.govinfo.gov/content/pkg/FR-1997-07-24/pdf/FR-1997-07-24.pdf
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FR-1997-07-24
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