[Federal Register Volume 64, Number 234 (Tuesday, December 7, 1999)]
[Notices]
[Page 68357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31608]



[[Page 68357]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-5047]


Draft Guidance for Industry on Pharmacokinetics in Patients With 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availability of a draft guidance for industry entitled 
``Pharmacokinetics in Patients With Impaired Hepatic Function: Study 
Design, Data Analysis, and Impact on Dosing and Labeling.'' This draft 
guidance provides recommendations to sponsors planning to conduct 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DATES: Submit written comments on the draft guidance for industry by 
February 7, 2000. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of this draft guidance for industry are available on 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copies of the draft guidance entitled ``Pharmacokinetics in Patients 
With Impaired Hepatic Function: Study Design, Data Analysis, and Impact 
on Dosing and Labeling'' to the Drug Information Branch (HFD-210), 
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Submit written comments on the draft guidance to the Dockets Management 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:
    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: FDA is announcing the availability of a 
draft guidance for industry entitled ``Pharmacokinetics in Patients 
With Impaired Hepatic Function: Study Design, Data Analysis, and Impact 
on Dosing and Labeling.'' This draft guidance provides recommendations 
on: (1) When pharmacokinetic studies in patients with hepatic 
impairments are or are not recommended; (2) the design and conduct of 
studies to characterize the effects of impaired hepatic function on the 
pharmacokinetics of a drug; (3) characteristics of 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.
     The draft guidance reflects the current view that the liver 
generally plays an important role in the elimination (metabolism and/or 
excretion) of a drug and that the effect of hepatic impairment on the 
elimination of a new drug should generally be defined during drug 
development.
     This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
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 statute, regulations, or 
both.
     Interested persons may, on or before February 7, 2000, submit to 
the Dockets Management Branch (address above) written comments on the 
draft guidance. 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 30, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-31608 Filed 12-6-99; 8:45 am]
BILLING CODE 4160-01-F