Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Drug Interaction Studies—Study Design, Data Analysis, and Implications for Dosing and Labeling.” This document is intended to provide recommendations to sponsors of new drug applications (NDAs), and biologic license applications (BLAs) for therapeutic biologics (drugs) on carrying out in vitro or in vivo drug-drug interaction studies. The draft guidance reflects the current view that the metabolism and transport of a new drug should be defined during drug development and that its interactions with other drugs should be explored as part of an adequate assessment of the safety and effectiveness of the drug.
Submit written or electronic comments on the draft guidance by November 13, 2006. General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies of this draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), 1401 Rockville Pike, Rockville, MD 20852-1448. 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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Shiew-Mei Huang, Center for Drug Evaluation and Research (HFD-850), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 4550, Silver Spring, MD 20993-0002, 301-796-1541, or
Toni Stifano, Center for Biologics Evaluation and Research (HFM-600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6190.End Further Info End Preamble Start Supplemental Information
FDA is announcing the availability of a draft guidance for industry entitled “Drug Interaction Studies—Study Design, Data Analysis, and Implications for Dosing and Labeling.” FDA previously published two guidance documents on the use of in vitro and in vivo approaches to study metabolism and metabolic drug-drug interactions entitled “Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies in Vitro” and “In Vivo Drug Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and Labeling.” The draft guidance, when finalized, will replace these guidance documents. This draft guidance discusses study design, choice of interacting drugs, data analysis, and provides recommendations for dosing and labeling.
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 Start Printed Page 53697on drug metabolism/transport and drug-drug interactions. 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.
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.
III. Electronic Access
Persons with access to the Internet may obtain the document at http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.Start Signature
Dated: September 5, 2006.
Assistant Commissioner for Policy.
[FR Doc. E6-15058 Filed 9-11-06; 8:45 am]
BILLING CODE 4160-01-S