[Federal Register: February 8, 2005 (Volume 70, Number 25)]
[Notices]
[Page 6697]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe05-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0030]
Draft Guidance for Industry on Clinical Lactation Studies--Study
Design, Data Analysis, and Recommendations for 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availability of a draft guidance for industry entitled ``Clinical
Lactation Studies--Study Design, Data Analysis, and Recommendations for
Labeling.'' This guidance discusses agency recommendations on how and
when to conduct clinical lactation studies and how to assess the
influence of drugs or biologic products on lactation. The goals of this
guidance are to provide the basic framework for designing, conducting,
and analyzing clinical lactation studies and to stimulate further study
and research to assist in rational therapeutics for lactating patients.
DATES: Submit written or electronic comments on the draft guidance by
April 11, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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 Submit written comments on the draft guidance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. The
guidance may also be obtained from CBER by mail by calling 1-800-835-
4709 or 301-827-1800. 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electronic access to the draft guidance document.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, or Toni M. Stifano,
Center for Biologics Evaluation and Research (HFM-600), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6190.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Clinical Lactation Studies--Study Design, Data Analysis, and
Recommendations for Labeling.'' This guidance is intended to provide
recommendations to sponsors and investigators on how to design,
conduct, and assess studies investigating the influence of lactation on
maternal pharmacokinetics (PK), and where appropriate, the
pharmacodynamics of drugs or biologic products, the extent of drug
transfer into breast milk, and the effects of drugs on milk production
and composition. Clinical lactation studies are usually not conducted
during the development of most products and lactating women are
actively excluded from trials. Consequently, at the time of a drug's
initial marketing, there are seldom meaningful human data on the
appropriate dosage and frequency of administration during lactation.
Even after years of marketing, data in product labels regarding
lactation rarely provide more information for appropriate prescribing
in lactation 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 lactation, the extent of drug transfer into breast milk, and the
effects of drugs on milk production and composition. Topics covered
include 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 lactating women and their breast-fed infants requires
specialized knowledge in a variety of areas, investigators designing
such studies are encouraged to obtain advice from experts in fields
including 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.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper 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: February 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2416 Filed 2-7-05; 8:45 am]
BILLING CODE 4160-01-S