Document ID: FDA-2012-D-0096-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry; Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations;  Availability
Posted Date: 2012-02-10T05:00Z

[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Notices]
[Pages 7166-7167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3096]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0096]

Draft Guidance for Industry on Determining the Extent of Safety 
Data Collection Needed in Late Stage Premarket and Postapproval 
Clinical Investigations; 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availability of a draft guidance for industry entitled ``Determining 
the Extent of Safety Data Collection Needed in Late Stage Premarket and 
Postapproval Clinical Investigations.'' This guidance is intended to 
assist sponsors of clinical investigations in determining the amounts 
and types of safety data to collect in trials conducted late in the 
development of a drug for marketing approval or after approval based on 
what is already known about a drug's safety profile. Extensive safety 
data are collected in clinical trials of investigational drugs to 
support marketing approval (premarket) and trials conducted after 
approval (postmarket). FDA believes that more selective or targeted 
safety data collection may be possible for some late stage premarket 
trials and postmarket trials because certain aspects of a drug's safety 
profile will be sufficiently well-established that comprehensive data 
collection is not needed. FDA believes more selective or targeted 
safety data collection in appropriate circumstances may improve the 
quality of the safety assessment without compromising the integrity of 
the trial results.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 10, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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; or 
Office of Communication, Outreach and Development (HFM-40), Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. 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: Lori Bickel, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6353, Silver Spring, MD 20993, 301-796-
0210; or Stephen Ripley, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Determining the Extent of Safety Data Collection Needed in 
Late Stage Premarket and Postapproval Clinical Investigations.'' This 
guidance is intended to assist clinical trial sponsors in determining 
the amounts and types of safety data that should be collected during 
late-stage premarket and postmarket clinical investigations of a drug 
product based on what is already known about the safety profile of the 
drug.
    To meaningfully weigh the risks and benefits of a drug, it is 
important to collect a broad range of safety-related data and develop a 
comprehensive safety profile of a drug. In some cases, however, certain 
aspects of the safety profile may be well-established prior to the 
completion of clinical trials to support marketing approval of an 
investigational drug. Similarly, for a marketed drug being studied for 
a new use, much of the existing safety profile for the approved use may 
be relevant to the new use. If certain aspects of a safety profile are 
well-established, it may not be necessary to collect certain types of 
safety data in clinical trials because the data would not contribute 
anything additional to the safety profile and may even have negative 
consequences (e.g., serve as a disincentive to clinical investigators). 
In those settings, more targeted or selective data collection can be 
used to focus on collecting data that will further contribute to the 
safety profile.
    The draft guidance identifies the types of safety data collected 
and recommends more selective or targeted safety data collection in a 
variety of circumstances, offers suggestions on methods that may be 
used to conduct selective or targeted data collection where 
appropriate, and highlights circumstances in which comprehensive data 
collection is generally needed.
    This draft guidance is being developed 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 determining 
the extent of safety data collection needed in late stage premarket and 
postapproval clinical investigations. 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

[[Page 7167]]

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. 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, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: February 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3096 Filed 2-9-12; 8:45 am]
BILLING CODE 4160-01-P