Document ID: FDA-2010-D-0451-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Suicidality; Prospective Assessment of Occurrence in Clinical Trials; Availability
Posted Date: 2010-09-09T04:00Z

[Federal Register: September 9, 2010 (Volume 75, Number 174)]
[Notices]               
[Page 54889-54890]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se10-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0451]

 
Draft Guidance for Industry on Suicidality: Prospective 
Assessment of Occurrence in Clinical Trials; 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availability of a draft guidance for industry entitled ``Suicidality: 
Prospective Assessment of Occurrence in Clinical Trials.'' The purpose 
of this guidance is to assist sponsors in prospectively assessing the 
occurrence of treatment-emergent suicidality in clinical trials of drug 
and biological products. Specifically, this guidance addresses FDA's 
current thinking regarding the importance of suicidality assessment in 
psychiatric and nonpsychiatric drug trials and the general principles 
for how best to accomplish this assessment during drug development.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 8, 2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://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: Thomas Laughren, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4114, Silver Spring, MD 20993-0002, 301-
796-2260.

[[Page 54890]]

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Suicidality: Prospective Assessment of Occurrence in 
Clinical Trials.'' The purpose of this guidance is to assist sponsors 
in prospectively assessing the occurrence of treatment-emergent 
suicidality in clinical trials of drug and biological products. 
Specifically, this guidance addresses FDA's current thinking regarding 
the importance of suicidality assessment in psychiatric and 
nonpsychiatric drug trials and the general principles for how best to 
accomplish this assessment during drug development.
    The principles discussed in this guidance for the prospective 
assessment of suicidality involve actively querying patients about the 
occurrence of suicidal thinking and behavior, rather than relying on 
patients to report such occurrences spontaneously, followed by 
retrospective classification of events into appropriate categories. 
This guidance recommends a specific suicidality assessment instrument 
that can be used to conduct such prospective assessments and offers 
guidance on the use of alternative instruments. This guidance does not 
address the complex analytic issues involved in the analysis of the 
suicidality data that will be derived from prospective assessments of 
suicidality; these issues will be addressed in separate guidances.
    Comments are welcome regarding the recommended approach of carrying 
out prospective suicidality assessments in all clinical trials for all 
drugs that are pharmacologically similar to isotretinoin and other 
tretinoins, beta blockers (especially those entering the brain), 
reserpine, drugs for smoking cessation, and drugs for weight loss for 
which possible signals of risk for suicidality have already been 
identified.
    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 the 
prospective assessment of suicidality occurrence in clinical trials. 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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: September 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22404 Filed 9-8-10; 8:45 am]
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