Draft Guidance for Industry on Systemic Lupus Erythematosus-Developing Drugs for Treatment; Availability, 15868 [05-6085]
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Federal Register / Vol. 70, No. 59 / Tuesday, March 29, 2005 / Notices
Administration, 9201 Corporate
Blvd., suite N316, Rockville, MD
20850, 301–827–2090; or
Jeffrey N. Siegel, Center for Drug
Evaluation and Research (HFD–
108), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–
5667.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0106]
Draft Guidance for Industry on
Systemic Lupus Erythematosus—
Developing Drugs for Treatment;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Systemic Lupus Erythematosus—
Developing Drugs for Treatment.’’ The
draft guidance is intended to provide
recommendations for industry on
developing drugs for the treatment of
systemic lupus erythematosus (SLE).
Specific topics include measurement of
lupus disease activity and clinical
outcomes, reduction in disease activity
and flares, treatment of organ-specific
disease, trial design issues and analysis,
surrogate markers as endpoints, and
risk-benefit assessment.
DATES: Submit written or electronic
comments on the draft guidance by June
27, 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single copies of the draft guidance to the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. 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comments on the draft guidance to the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 https://www.fda.gov/dockets/
ecomments. Send one self-addressed
adhesive label to assist the office in
processing your requests. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Joel Schiffenbauer, Center for Drug
Evaluation and Research (HFD–
550), Food and Drug
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Systemic Lupus Erythematosus—
Developing Drugs for Treatment.’’ SLE
is a chronic disease characterized by
protean manifestations often
demonstrating a waxing and waning
course. In the past, a diagnosis of SLE
often implied a decreased life span due
to internal organ system involvement or
to toxic effects of therapy. However,
recent improvements in care have
dramatically enhanced the survival of
SLE patients with the most severe and
life-threatening manifestations.
Unfortunately, current treatments for
SLE remain inadequate as many patients
have incompletely controlled the
disease, progression to end-stage organ
involvement continues, and current
therapies carry potential risks of
debilitating side effects. Therefore, it is
important to clearly describe acceptable
endpoints for approval to facilitate the
development of novel therapeutic agents
which have the potential to be more
effective and/or less toxic.
This draft guidance provides a general
discussion of outcomes and
measurements of lupus disease activity
including the use of disease activity
indices, flares, and organ-specific
outcomes. It presents the indications
that the agency may be willing to
approve at present for new drug
therapies for lupus. It also presents
general trial design issues, discusses the
use of surrogate endpoints in relation to
lupus, presents the overall risk-benefit
assessment that should be addressed for
any new therapy of lupus, and presents
some issues related to lupus and
pharmacokinetics.
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 any 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 may be seen 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 https://
www.fda.gov/ohrms/dockets/
default.htm or https://www.fda.gov/cder/
guidance/index.htm.
Dated: March 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–6085 Filed 3–28–05; 8:45 am]
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Bureau of Customs and Border
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Cancellation of Customs Broker
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Holder
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ACTION: General notice.
AGENCY:
SUMMARY: Notice is hereby given that,
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Manuel A. Gonzalez ...................................................................................................................................................
Sherry A. Ireland .........................................................................................................................................................
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VerDate jul<14>2003
17:01 Mar 28, 2005
Jkt 205001
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]]>Agencies
[Federal Register Volume 70, Number 59 (Tuesday, March 29, 2005)]
[Notices]
[Page 15868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6085]
[[Page 15868]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0106]
Draft Guidance for Industry on Systemic Lupus Erythematosus--
Developing Drugs for Treatment; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Systemic Lupus
Erythematosus--Developing Drugs for Treatment.'' The draft guidance is
intended to provide recommendations for industry on developing drugs
for the treatment of systemic lupus erythematosus (SLE). Specific
topics include measurement of lupus disease activity and clinical
outcomes, reduction in disease activity and flares, treatment of organ-
specific disease, trial design issues and analysis, surrogate markers
as endpoints, and risk-benefit assessment.
DATES: Submit written or electronic comments on the draft guidance by
June 27, 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. 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 https://www.fda.gov/dockets/ecomments.
Send one self-addressed adhesive label to assist the office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Joel Schiffenbauer, Center for Drug Evaluation and Research (HFD-
550), Food and Drug Administration, 9201 Corporate Blvd., suite N316,
Rockville, MD 20850, 301-827-2090; or
Jeffrey N. Siegel, Center for Drug Evaluation and Research (HFD-
108), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-594-5667.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Systemic Lupus Erythematosus--Developing Drugs for
Treatment.'' SLE is a chronic disease characterized by protean
manifestations often demonstrating a waxing and waning course. In the
past, a diagnosis of SLE often implied a decreased life span due to
internal organ system involvement or to toxic effects of therapy.
However, recent improvements in care have dramatically enhanced the
survival of SLE patients with the most severe and life-threatening
manifestations. Unfortunately, current treatments for SLE remain
inadequate as many patients have incompletely controlled the disease,
progression to end-stage organ involvement continues, and current
therapies carry potential risks of debilitating side effects.
Therefore, it is important to clearly describe acceptable endpoints for
approval to facilitate the development of novel therapeutic agents
which have the potential to be more effective and/or less toxic.
This draft guidance provides a general discussion of outcomes and
measurements of lupus disease activity including the use of disease
activity indices, flares, and organ-specific outcomes. It presents the
indications that the agency may be willing to approve at present for
new drug therapies for lupus. It also presents general trial design
issues, discusses the use of surrogate endpoints in relation to lupus,
presents the overall risk-benefit assessment that should be addressed
for any new therapy of lupus, and presents some issues related to lupus
and pharmacokinetics.
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 any 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 may be seen 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
https://www.fda.gov/ohrms/dockets/default.htm or https://www.fda.gov/
cder/guidance/index.htm.
Dated: March 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6085 Filed 3-28-05; 8:45 am]
BILLING CODE 4160-01-S
