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Regulatory Information
2004_register
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2010-09-23
article
Determination of Regulatory Review Period for Purposes of Patent Extension; FABRAZYME
Notices
D09002ee1bdea82f2
D09002ee1bdea8380
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) has determined the regulatory review period for FABRAZYME and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
69 FR 12159
https://www.govinfo.gov/app/details/FR-2004-03-15/04-5760
04-5760
fr15mr04-69
4160-01-S
Docket No. 2003E-0406
https://www.govinfo.gov/app/details/FR-2004-03-15/04-5760
https://www.govinfo.gov/content/pkg/FR-2004-03-15/html/04-5760.htm
https://www.govinfo.gov/content/pkg/FR-2004-03-15/pdf/04-5760.pdf
2 p.
12159
12160
69 FR 12159
Determination of Regulatory Review Period for Purposes of Patent Extension; FABRAZYME; Federal Register Vol. 69, Issue
NOTICE
04-5760
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2003E-0406
4160-01-S
04-5760
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for FABRAZYME and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Claudia Grillo, Office of Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-453-6699.
Patent extension; regulatory review period determinations
Patent extension; regulatory review period determinations
FABRAZYME,
Federal Register
Vol. 69, no. 50
Office of the Federal Register, National Archives and Records Administration
2004-03-15
continuing
daily
deposited
born digital
224 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2004-03-15
P0b002ee1809769fe
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr15mr04
https://www.govinfo.gov/app/details/FR-2004-03-15
https://www.govinfo.gov/content/pkg/FR-2004-03-15/pdf/FR-2004-03-15.pdf
https://www.govinfo.gov/content/pkg/FR-2004-03-15/xml/FR-2004-03-15.xml
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12264
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2010-09-23
2023-05-04
FR-2004-03-15
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FR
FR-2004-03-15
69
50