[Federal Register Volume 63, Number 223 (Thursday, November 19, 1998)]
[Notices]
[Pages 64269-64270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30937]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1001]


Draft Guidance for Industry: In Vivo Drug Metabolism/Drug 
Interaction Studies--Study Design, Data Analysis, and Recommendations 
for Dosing and Labeling; Availability

AGENCY: Food and Drug Administration, HHS.


[[Page 64270]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``In Vivo Drug 
Metabolism/Drug Interaction Studies--Study Design, Data Analysis, and 
Recommendations for Dosing and Labeling.'' This draft guidance is 
intended to provide recommendations to sponsors and applicants of new 
drug applications (NDA's) and biologics license applications (BLA's) 
for therapeutic biologics (hereafter drugs) on carrying out in vivo 
drug metabolism and metabolic drug-drug interaction studies. The draft 
guidance reflects the current view that the metabolism of a new drug 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.

DATES: Written comments may be submitted on the draft guidance by 
January 19, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of ``In Vivo Drug Metabolism/Drug Interaction 
Studies--Study Design, Data Analysis, and Recommendations for Dosing 
and Labeling'' are available on the Internet at ``http://www.fda.gov/
cder/guidance/index.htm'' or ``http://www.fda.gov/cber/
guidelines.htm''. Submit written requests for single copies of the 
draft guidance to the Drug Information Branch (HFD-210), Center for 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, FAX 888-CBERFAX or 301-827-3844. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the draft guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Shiew Mei Huang, Center for Drug 
Evaluation and Research (HFD-850), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5671, or David Green, Center 
for Biologics Evaluation and Research (HFM-579), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-5349.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``In Vivo Drug Metabolism/Drug 
Interaction Studies--Study Design, Data Analysis, and Recommendations 
for Dosing and Labeling.'' Previous guidance from FDA on the use of in 
vitro approaches to study metabolism and metabolic drug-drug 
interactions is available in a document entitled ``Drug Metabolism/Drug 
Interaction Studies in the Drug Development Process: Studies in 
Vitro.'' The present guidance should be viewed as a companion to this 
earlier guidance. The present guidance discusses study design, choice 
of interacting drugs, and data analysis and provides recommendations 
for dosing and labeling.
    This draft level 1 guidance document is being issued consistent 
with FDA's good guidance practices (62 FR 8961, February 27, 1997). It 
represents the agency's current thinking on drug metabolism 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 statute, regulations, or both.
    Interested persons may, at any time, submit written comments on the 
draft guidance to the Dockets Management Branch (address above). Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. The draft guidance 
and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: November 13, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-30937 Filed 11-18-98; 8:45 am]
BILLING CODE 4160-01-F