[Federal Register Volume 72, Number 217 (Friday, November 9, 2007)]
[Notices]
[Page 63618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21985]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0419]


Draft Guidance for Industry on Chronic Obstructive Pulmonary 
Disease: Developing Drugs for Treatment; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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availability of a draft guidance for industry entitled ``Chronic 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.

DATES: 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 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 COPD. The emphasis of this guidance is on the 
assessment of efficacy of a new molecular entity in phase 3 clinical 
studies of COPD.
    There is pressing need to develop new drugs for COPD because the 
global prevalence of COPD is rising, the disease is associated with 
significant morbidity and mortality, and current treatment options are 
limited. The currently available drugs for COPD are mostly for 
symptomatic treatment and have not been conclusively shown to alter the 
underlying inflammation or to alter disease progression. The principles 
of development applied to COPD drugs have been generally derived from 
those used to develop drugs for asthma, with the primary focus aimed at 
demonstrating improvements in airway obstruction. With improved 
understanding of the pathophysiology and clinical manifestations of 
COPD, and the awareness of the importance of inflammation in COPD and 
how this inflammation differs from that occurring in asthma, this is an 
appropriate time to define characteristics of specific drug development 
programs for COPD.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on developing 
drugs for the treatment of COPD. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: November 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21985 Filed 11-8-07; 8:45 am]
BILLING CODE 4160-01-S