E6-3713. Guidance for Industry on Nonclinical Safety Evaluation of Drug or Biologic Combinations; 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 ``Nonclinical Safety Evaluation of Drug or Biologic Combinations.'' This guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), co-packaged products, and some adjunctive therapies.

DATES:

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

ADDRESSES:

Submit written requests for single copies of this 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 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Abigail C. Jacobs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6484, Silver Spring, MD 20993-0002, 301-796-0174.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Nonclinical Safety Evaluation of Drug or Biologic Combinations.” This guidance provides recommendations on nonclinical approaches to support the clinical study and approval of FDCs, co-packaged products, and some adjunctive therapies. The intent of this guidance is to delineate general guiding principles.

In the Federal Register of January 26, 2005 (70 FR 3714), FDA announced the availability of a draft guidance entitled “Nonclinical Safety Evaluation of Drug Combinations.” This notice gave interested persons an opportunity to submit comments. As a result of the comments, certain sections of this guidance have been reworded to improve clarity. Additionally, the following revisions have been made to the guidance: (1) The inclusion of combinations of biologics regulated by the Center for Drug Evaluation and Research and drugs, (2) a narrowing of the description of “adjunctive therapies” covered by the guidance, and (3) a clarification of the aspects of the developmental reproductive toxicology sections.

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 nonclinical safety evaluation of drug and biologic combinations. 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 on the guidance at any time. 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. The guidance and 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: March 7, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.