Draft Guidance for Industry on Clinical Lactation Studies-Study Design, Data Analysis, and Recommendations for Labeling; Availability, 6697 [05-2416]
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Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices
V. Electronic Access
Copies of the guidance document
entitled ‘‘Guidance for Industry: Animal
Drug Sponsor Fees Under the Animal
Drug User Fee Act’’ may be obtained
from the CVM home page (https://
www.fda.gov/cvm) and from the
Division of Dockets Management Web
site (https://www.fda.gov/ohrms/dockets/
default.htm).
Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2417 Filed 2–7–05; 8:45 am]
BILLING CODE 4160–01–S
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Draft Guidance for Industry on Clinical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.
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availability of a draft guidance for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comments on the draft guidance by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single copies of the draft guidance to the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.
VerDate jul<14>2003
18:12 Feb 07, 2005
Jkt 205001
Submit written comments on the draft
guidance to the Division of Dockets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 https://
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,
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
6697
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:/
/www.fda.gov/cder/guidance/index.htm
or https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0022]
International Conference on
Harmonisation; Draft Guidance on S8
Immunotoxicity Studies for Human
Pharmaceuticals; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\08FEN1.SGM
Notice.
08FEN1
]]>Agencies
[Federal Register Volume 70, Number 25 (Tuesday, February 8, 2005)]
[Notices]
[Page 6697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2416]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://www.fda.gov/cder/guidance/index.htm or https://
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
