[Federal Register: May 30, 2003 (Volume 68, Number 104)]
[Notices]
[Page 32531]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my03-89]
[[Page 32531]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-5047]
Guidance for Industry on Pharmacokinetics in Patients With
Impaired Hepatic Function: Study Design, Data Analysis, and Impact on
Dosing and Labeling; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Pharmacokinetics in
Patients With Impaired Hepatic Function: Study Design, Data Analysis,
and Impact on Dosing and Labeling.'' This guidance provides
recommendations to sponsors planning to conduct studies to assess the
influence of hepatic impairment on the pharmacokinetics and, where
appropriate, the pharmacodynamics of drugs or therapeutic biologics.
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, or to the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research, Food and Drug Administration, 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 guidance to the Dockets Management Branch (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:
Mehul U. Mehta, Center for Drug Evaluation and Research (HFD-860),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-594-2567; 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:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Pharmacokinetics in Patients With Impaired Hepatic Function:
Study Design, Data Analysis, and Impact on Dosing and Labeling.'' This
document provides guidance on: (1) When pharmacokinetic studies in
patients with hepatic impairments should be conducted; (2) the
recommended design and conduct of studies to characterize the effects
of impaired hepatic function on the pharmacokinetics of a drug; (3)
inclusion criteria for patient populations to be studied; (4) analysis,
interpretation, and reporting of the results of the studies; and (5)
the description of study results in drug labeling.
In the Federal Register of December 7, 1999 (64 FR 68357), FDA
published a notice announcing the availability of a draft version of
this guidance. A number of comments were received in the docket for the
1999 draft guidance. After careful consideration of the comments, the
draft guidance was revised. Although we made a number of clarifying
edits and tried to make the guidance more user friendly, the only
substantive change to the draft guidance was to correct the implication
that certain drugs should be studied in patients with concurrent
hepatic and renal impairment.
This level 1 final 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 pharmacokinetic studies in
patients with impaired hepatic function. 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 Dockets Management Branch (see
ADDRESSES) written or electronic comments on the guidance at any time.
Two copies of mailed 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
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.
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
http://www.fda.gov/ohrms/dockets/default.htm.
Dated: May 22, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13477 Filed 5-29-03; 8:45 am]
BILLING CODE 4160-01-S