[Federal Register: November 1, 2004 (Volume 69, Number 210)]
[Notices]
[Page 63402-63403]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01no04-96]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0459]
Draft Guidance for Industry on Pharmacokinetics in Pregnancy--
Study Design, Data Analysis, and Impact on Dosing and Labeling
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availability of a draft guidance for industry entitled ``Draft Guidance
for Industry on Pharmacokinetics in Pregnancy--Study Design, Data
Analysis, and Impact on Dosing and Labeling.'' This guidance discusses
agency recommendations on issues to consider when designing and
[[Page 63403]]
conducting pharmacokinetic (PK) studies in pregnant women and,
specifically, on how to assess the influence of pregnancy on the PKs,
and where appropriate, the pharmacodynamics (PD) of drugs or biologic
products. The goals of this guidance are to recommend a framework for
designing and conducting PK studies in pregnant women and stimulate
further study and research to assist in rational therapeutics for
pregnant patients.
DATES: Submit written or electronic comments on the draft guidance by
January 3, 2005. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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 Communications, 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 Submit written comments on the draft guidance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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
FOR FURTHER INFORMATION CONTACT: Kathleen Uhl, Center for Drug
Evaluation and Research (HFD-020), Food and Drug Administration, 5515
Security Lane, Rockville, MD 20852, 301-443-5157.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Draft Guidance for Industry on Pharmacokinetics in
Pregnancy--Study Design, Data Analysis, and Impact on Dosing and
Labeling.'' This guidance is intended to provide recommendations to
sponsors and investigators on how to design, conduct, and assess
studies investigating the influence of pregnancy on the
pharmacokinetics, and where appropriate, the pharmacodynamics of drugs
or biologic products. During the clinical development of most products,
pregnant women are actively excluded from trials, and, if pregnancy
does occur during a trial, the usual procedure is to discontinue
treatment and drop the patient from the study. Consequently, at the
time of a drug's initial marketing, except for products developed to
treat conditions specific to pregnancy, there are seldom meaningful
human data on the appropriate dosage and frequency of administration
during pregnancy. Even after years of marketing, data in product labels
regarding PK and dose adjustments during pregnancy rarely provide more
information for appropriate prescribing in pregnancy than what was
available at the time of initial marketing.
The information in this guidance is intended to promote an increase
in the amount of useful data concerning how drug kinetics are affected
by pregnancy and to further encourage the development of appropriate
therapeutic treatments for pregnant women. Topics covered include
ethical considerations associated with conducting PK studies in
pregnant women, study design, data analysis, labeling, and
considerations for future research. The agency recommends using this
guidance in conjunction with other pharmacological and clinical
literature on the design, conduct, and interpretation of PK studies.
Because the conduct of studies in pregnant women requires specialized
knowledge in a variety of areas, investigators designing such studies
are encouraged to obtain advice from experts in fields such as
obstetrics, pediatrics, pharmacology, clinical pharmacology,
pharmacometrics, statistics, and other applicable disciplines.
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 on this topic.
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 Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
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
draft guidance and received comments are available for public
examination 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
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
Dated: October 21, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24308 Filed 10-29-04; 8:45 am]
BILLING CODE 4160-01-S