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FDA is announcing the availability of a guidance for industry entitled “Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the overall clinical development program of drugs to support an indication for the treatment of ABECB-COPD. This guidance finalizes the revised draft guidance published on August 22, 2008 (73 FR 49684), which in turn revised the draft guidance for industry entitled “Acute Bacterial Exacerbations of Chronic Bronchitis—Developing Antimicrobial Drugs for Treatment” published in 1998. Changes from the revised draft guidance are incorporated into the appropriate sections of the guidance and were based on comments submitted to the docket for the draft guidance. In addition, developments in scientific and medical information and technology in the treatment of ABECB-COPD are reflected in this guidance. This guidance fulfills the requirement set forth in the Food and Drug Administration Amendments Act of 2007 that directed FDA to update the ABECB-COPD guidance within 5 years.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on developing drugs for the treatment of ABECB-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.
This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under 0910-0014; the collections of information in 21 CFR
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