[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Notices]
[Pages 9396-9397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02863]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0077]
Draft Guidance for Industry on Alzheimer's Disease: Developing
Drugs for the Treatment of Early Stage Disease; 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availability of a draft guidance for industry entitled ``Alzheimer's
Disease: Developing Drugs for the Treatment of Early Stage Disease.''
This guidance outlines FDA's current thinking as to how a sponsor could
demonstrate efficacy in clinical trials in patients in the early stages
of Alzheimer's disease that occur before the onset of overt dementia.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 9, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Nicholas A. Kozauer, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4351,
[[Page 9397]]
Silver Spring, MD 20993-0002, 301-796-2250.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of
Early Stage Disease.'' This guidance outlines FDA's current thinking as
to how a sponsor could demonstrate efficacy in clinical trials in
patients in the early stages of Alzheimer's disease (AD) that occur
before the onset of overt dementia. Specifically, this guidance
addresses FDA's current thinking regarding the selection of patients
with early AD, or who are determined to be at risk of developing AD,
for enrollment into clinical trials. The selection of outcome measures
for trials in these populations that are designed to demonstrate a
clinical benefit, as well as the manner in which disease modification
might be demonstrated, are also addressed. The design of clinical
trials that are specifically focused on the treatment of patients with
established Alzheimer's disease dementia (i.e., dementia of the
Alzheimer's type), or any of the autosomal dominant forms of AD, are
not explicitly discussed although many of the principles in this
guidance will be pertinent.
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 developing
drugs for the treatment of early Alzheimer's disease. 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 either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: February 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02863 Filed 2-7-13; 8:45 am]
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