E9-8833. Draft Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Submission of Summary Bioequivalence Data for ANDAs.” The draft guidance is intended to assist abbreviated new drug application (ANDA) applicants in complying with the new requirements in the final rule on the submission of bioequivalence data published in the Federal Register in January 2009. The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The draft guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs, and is applicable to BE studies conducted during both preapproval and postapproval periods.

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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by July 16, 2009.

ADDRESSES:

Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Aida L. Sanchez, Center for Drug Evaluation and Research (HFD-650), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5847.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 29, 2003 (68 FR 61640), FDA published a proposed rule to require an ANDA applicant to submit data from all BE studies that the applicant conducts on a drug product formulation submitted for approval. The agency's final rule amending its bioequivalence regulations was published in the Federal Register on January 16, 2009 (74 FR 2849). All BE studies conducted on the same drug product formulation, including studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria, must be submitted to the agency. Information from all BE studies is important to the agency for the following reasons:

• Data contained in any BE study could be important to FDA's assessment of bioequivalence for a specific product; and
• Even when additional BE studies are not critical to the agency's bioequivalence determination for the specific product being reviewed, the data provide valuable scientific information that increases the agency's knowledge and understanding of bioequivalence and generic drug development and promotes further development of science-based bioequivalence policies.

II. The Draft Guidance

FDA is announcing the availability of a draft guidance for industry entitled “Submission of Summary Bioequivalence Data for ANDAs.” The draft guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs. The draft guidance provides information on the following subjects:

• The types of ANDA submissions covered by the new regulations on BE studies;
• A recommended format for summary reports of BE studies; and
• What formulations FDA considers the “same drug product formulation” for different dosage forms based on differences in composition.

The draft guidance is applicable to BE studies conducted for ANDAs during both preapproval and postapproval periods.

The 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 summary bioequivalence data reports to be submitted in 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.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. 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.

IV. Paperwork Reduction Act of 1995

The draft guidance refers to information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 314.94(a)(7), 314.96(a)(1), and 314.97 have been approved under OMB control number 0910-0630.

V. 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.regulations.gov.

Dated: April 9, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.