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2010-09-23
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Final Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007; Availability
Notices
D09002ee1bdd7c52b
D09002ee1bdd7c5c7
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 guidance for industry entitled ``Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007'' dated January 2009. The guidance provides sponsors, industry, researchers, investigators, and FDA staff with the agency's current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA and accompanying certifications as described in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
74 FR 3614
https://www.govinfo.gov/app/details/FR-2009-01-21/E9-1183
E9-1183
FR21JA09-85
4160-01-S
Docket No. FDA-2008-D-0224
https://www.govinfo.gov/app/details/FR-2009-01-21/E9-1183
https://www.govinfo.gov/content/pkg/FR-2009-01-21/html/E9-1183.htm
https://www.govinfo.gov/content/pkg/FR-2009-01-21/pdf/E9-1183.pdf
2 p.
3614
3615
74 FR 3614
Final Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007; Availability; Federal Register Vol. 74, Issue
NOTICE
E9-1183
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2008-D-0224
4160-01-S
E9-1183
Notice.
The Food and Drug Administration (FDA or agency) is announcing the availability of a guidance for industry entitled ``Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007'' dated January 2009. The guidance provides sponsors, industry, researchers, investigators, and FDA staff with the agency's current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA and accompanying certifications as described in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Submit written or electronic comments on agency guidances at any time.
Jarilyn Dupont, Office of Policy, Office of Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4305, Silver Spring, MD 20993-0002, 301- 796-4830.
Final Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff:
Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions; Compliance, etc.
,
ClinicalTrials.gov
http://prsinfo.clinicaltrials.gov
http://www.fda.gov/oc/initiatives/advance/fdaaa.html
http://www.regulations.gov
www.ClinicalTrials.gov
Federal Register
Vol. 74, no. 12
Office of the Federal Register, National Archives and Records Administration
2009-01-21
continuing
daily
deposited
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576 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2009-01-21
P0b002ee1809a8c29
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:FR21JA09
https://www.govinfo.gov/app/details/FR-2009-01-21
https://www.govinfo.gov/content/pkg/FR-2009-01-21/pdf/FR-2009-01-21.pdf
https://www.govinfo.gov/content/pkg/FR-2009-01-21/xml/FR-2009-01-21.xml
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2010-09-23
2023-05-02
FR-2009-01-21
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FR
FR-2009-01-21
74
12