[Federal Register Volume 75, Number 174 (Thursday, September 9, 2010)]
[Notices]
[Pages 54889-54890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22404]
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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Draft Guidance for Industry on Suicidality: Prospective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availability of a draft guidance for industry entitled ``Suicidality: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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 8, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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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