Document ID: FDA-2005-D-0224-0005
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Systemic Lupus ErythematosusDeveloping Medical Products for Treatment; Availability
Posted Date: 2010-06-22T04:00Z

[Federal Register: June 22, 2010 (Volume 75, Number 119)]
[Notices]               
[Page 35493-35494]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn10-59]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0224] (formerly Docket No. 2005D-0106)

 
Guidance for Industry on Systemic Lupus Erythematosus--Developing 
Medical Products for Treatment; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Systemic Lupus 
Erythematosus--Developing Medical Products for Treatment.'' This 
guidance provides recommendations for industry on developing human 
drugs, therapeutic biological products, and medical devices for the 
treatment of systemic lupus erythematosus (SLE). This guidance 
finalizes the draft guidance entitled ``Systemic Lupus Erythematosus--
Developing Drugs for Treatment'' (the draft guidance). Elsewhere in 
this issue of the Federal Register, FDA is announcing the availability 
of the guidance entitled ``Lupus Nephritis Caused by Systemic Lupus 
Erythematosus--Developing Medical Products for Treatment,'' which 
finalizes the parts of the draft guidance regarding lupus nephritis.

DATES:  Submit either electronic or written comments on agency 
guidances at any time.

ADDRESSES:  Submit written requests for single copies of this 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; the 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; or the Division 
of Small Manufacturers, International, and Consumer Assistance (HFZ-
220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. The guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send one self-addressed adhesive label to assist the offices in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

[[Page 35494]]

    Submit electronic comments on the 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:  Jeffrey Siegel, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 3154, Silver Spring, MD 20993-0002, 301-
796-2280; or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852, 301-827-6210; or
    Sahar M. Dawisha, Office of In Vitro Diagnostic Devices, Center for 
Devices and Radiological Health (HFZ-440), Food and Drug 
Administration, 2098 Gaither Rd., rm. 374, Rockville, MD 20850, 240-
276-0717.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Systemic Lupus Erythematosus--Developing Medical Products 
for Treatment.'' This guidance is intended to assist sponsors in the 
clinical development of medical products for the treatment of SLE. The 
guidance addresses the overall development program and clinical trial 
designs as well as specific information on claims, study design, study 
duration, efficacy endpoints, and response criteria.
    In the Federal Register of March 29, 2005 (70 FR 15868), FDA 
announced the availability of a draft guidance entitled ``Systemic 
Lupus Erythematosus--Developing Drugs for Treatment.'' FDA received a 
number of comments on the draft guidance, which were considered and 
incorporated, as appropriate, when finalizing the guidance. The 
recommendations regarding medical product development for lupus 
nephritis were removed from this guidance and placed into a separate 
guidance, the availability of which is announced elsewhere in this 
issue of the Federal Register. Additional organ-specific guidances will 
be developed in the future. Other changes that were made include the 
addition of more specific examples of trial design and study endpoints, 
updating the science, and minor editorial changes to clarify specific 
issues. In addition, input was obtained from the Center for Biologics 
Evaluation and Research and the Center for Devices and Radiological 
Health.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on developing medical products for the 
treatment of SLE. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 312 have been approved under 
OMB Control No. 0910-0014; the collections of information in 21 CFR 
part 314 have been approved under OMB Control No. 0910-0001; the 
collections of information in 21 CFR part 601 have been approved under 
OMB Control No. 0910-0338; and the collections of information in 21 CFR 
part 812 have been approved under OMB Control No. 0910-0078.

III. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15080 Filed 6-21-10; 8:45 am]
BILLING CODE 4160-01-S