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2014-05-29
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Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Availability
Notices
D09002ee1bdd9dcae
D09002ee1bdd9e12d
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.'' This guidance is intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for the treatment of chronic obstructive pulmonary disease (COPD). The emphasis of this guidance is on the assessment of efficacy of a new molecular entity in phase 3 clinical studies of COPD.
72 FR 63618
https://www.govinfo.gov/app/details/FR-2007-11-09/E7-21985
E7-21985
fr09no07-81
4160-01-S
Docket No. 2007D-0419
https://www.govinfo.gov/app/details/FR-2007-11-09/E7-21985
https://www.govinfo.gov/content/pkg/FR-2007-11-09/html/E7-21985.htm
https://www.govinfo.gov/content/pkg/FR-2007-11-09/pdf/E7-21985.pdf
1 p.
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Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Availability; Federal Register Vol. 72, Issue
NOTICE
E7-21985
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2007D-0419
4160-01-S
E7-21985
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.'' This guidance is intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for the treatment of chronic obstructive pulmonary disease (COPD). The emphasis of this guidance is on the assessment of efficacy of a new molecular entity in phase 3 clinical studies of COPD.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 8, 2008.
Badrul A. Chowdhury, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 3316, Silver Spring, MD 20993-0002, 301- 796-2300.
Reports and guidance documents; availability, etc.:
Chronic Obstructive Pulmonary Disease; treatment drugs development,
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 72, no. 217
Office of the Federal Register, National Archives and Records Administration
2007-11-09
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347 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2007-11-09
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0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr09no07
https://www.govinfo.gov/app/details/FR-2007-11-09
https://www.govinfo.gov/content/pkg/FR-2007-11-09/pdf/FR-2007-11-09.pdf
https://www.govinfo.gov/content/pkg/FR-2007-11-09/xml/FR-2007-11-09.xml
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