[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Draft Guidance for Industry on Alzheimer's Disease: Developing 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availability of a draft guidance for industry entitled ``Alzheimer's 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 9, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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    FDA is announcing the availability of a draft guidance for industry 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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