Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products.” This guidance describes a new process for making available recommendations on how to design product-specific bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs are able to access BE study guidance on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and will provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations.

DATES:

Submit either electronic or written comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit electronic comments on the guidance to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Doan T. Nguyen, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9314.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products.” This guidance describes a new process for making available recommendations on how to design product-specific BE studies to support ANDAs. Under this process, draft and final BE recommendations are posted on FDA's Web site ( http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm , Individual Product Bioequivalence Recommendations) and announced periodically in the Federal Register. For draft BE recommendations, the Federal Register notice will identify a comment period. The public is encouraged to submit comments on the draft BE recommendations, and the agency will consider received comments in developing final BE recommendations. FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and provide an opportunity for the public to consider and comment on those recommendations.

In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft version of this guidance entitled “Bioequivalence Recommendations for Specific Products.” The May 2007 draft guidance gave interested persons an opportunity to submit comments through August 29, 2007. The agency is finalizing the guidance after considering comments received on the draft guidance. Minor changes were made to the draft guidance to update FDA Web site information.

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 a new process for making available to sponsors FDA guidance on how to design product-specific bioequivalence studies to support ANDAs. 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) either electronic or written comments regarding the guidance. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov .