[Federal Register: November 19, 1998 (Volume 63, Number 223)]
[Notices]
[Page 64269-64270]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no98-82]

-----------------------------------------------------------------------

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Draft Guidance for Industry: In Vivo Drug Metabolism/Drug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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry entitled ``In Vivo Drug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 This draft guidance is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 The draft
guidance reflects the current view that the metabolism of a new drug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DATES: Written comments may be submitted on the draft guidance by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draft guidance to the Drug Information Branch (HFD-210), Center for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Submit written comments on the draft guidance to the Dockets Management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