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Notice

Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Availability

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.”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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 8, 2008.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Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

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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.

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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FDA is announcing the availability of a draft guidance for industry entitled “Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.”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.

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Dated: November 2, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E7-21985 Filed 11-8-07; 8:45 am]

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