United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2016_register
executive
2016-09-17
article
A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket
Notices
D09002ee1c1dc08d0
D09002ee1c1dc095d
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (such as academic researchers, regulated industries, consortia, and patient groups) on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities (NMEs) and New Biological Therapeutics from October 2007 to December 2015. Comments received on this list will help FDA determine the utility of the list and may assist FDA in developing databases on biomarkers for drug development in the future.
81 FR 64177
https://www.govinfo.gov/app/details/FR-2016-09-19/2016-22470
2016-22470
fr19se16-62
4164-01-P
Docket No. FDA-2016-N-2610
https://www.govinfo.gov/app/details/FR-2016-09-19/2016-22470
https://www.govinfo.gov/content/pkg/FR-2016-09-19/html/2016-22470.htm
https://www.govinfo.gov/content/pkg/FR-2016-09-19/pdf/2016-22470.pdf
2 p.
64177
64178
81 FR 64177
A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket; Federal Register Vol. 81, Issue
NOTICE
2016-22470
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2016-11-18
Docket No. FDA-2016-N-2610
4164-01-P
2016-22470
Notice; establishment of docket; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (such as academic researchers, regulated industries, consortia, and patient groups) on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities (NMEs) and New Biological Therapeutics from October 2007 to December 2015. Comments received on this list will help FDA determine the utility of the list and may assist FDA in developing databases on biomarkers for drug development in the future.
Submit either electronic or written comments by November 18, 2016.
Marianne Noone, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 4528, Silver Spring, MD 20993-0002, 301- 796-2600.
List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics October 2007 to December 2015
,
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 181
Office of the Federal Register, National Archives and Records Administration
2016-09-19
continuing
daily
deposited
born digital
305 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-09-19
P0b002ee19137043f
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr19se16
https://www.govinfo.gov/app/details/FR-2016-09-19
https://www.govinfo.gov/content/pkg/FR-2016-09-19/pdf/FR-2016-09-19.pdf
https://www.govinfo.gov/content/pkg/FR-2016-09-19/xml/FR-2016-09-19.xml
fdlp
64049
64343
DGPO
2016-09-17
2023-11-02
FR-2016-09-19
machine generated
eng
FR
FR-2016-09-19
81
181