[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Notices]
[Pages 32667-32668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12922]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0571]
Draft Guidance for Industry on Rheumatoid Arthritis: Developing
Drug Products for Treatment; 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availability of a draft guidance for industry entitled ``Rheumatoid
Arthritis: Developing Drug Products for Treatment.'' This guidance
outlines FDA's current thinking on the principles of clinical
development relevant to dose-selection and assessment of efficacy and
safety to support the approval of drug products for the treatment of
patients with rheumatoid arthritis (RA). It also addresses additional
considerations for drug products developed as drug-device combination
products. This guidance revises the guidance for industry entitled
``Clinical Development Programs for Drugs, Devices, and Biological
Products for the Treatment of Rheumatoid Arthritis (RA),'' published in
February 1999.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 30, 2013.
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; or Office of Communication,
Outreach, and Development (HFM-40), Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448; or the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, 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access to the draft guidance document.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: Nikolay Nikolov, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3335, Silver Spring, MD 20993-0002, 301-
796-5281; 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; or Markham Luke
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1680, Silver
Spring, MD 20993-0002, 301-796-5556.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Rheumatoid Arthritis: Developing Drug Products for
Treatment.'' This draft guidance reflects current FDA thinking on RA
drug product development. FDA's current thinking has been influenced by
clinical development programs conducted for RA since the 1999 guidance
published, and by changes in the standard of care for RA because of
availability of many effective treatments. RA drug product development
has evolved to reflect the current status of the RA therapeutic
armamentarium, good clinical practice, and treatment goals.
The draft guidance addresses:
Dose(s) and dosing regimen(s) selection throughout the
clinical development program.
Expectations for establishing efficacy in RA based on
signs and symptoms and physical function domains.
Use of efficacy endpoints such as clinical remission and
prevention of structural damage progression.
Limiting the use of placebo.
Use of active comparator for safety and efficacy trials.
Principles of safety assessment.
Development of drug-device combination products.
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
drug products for the treatment of RA. 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. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that 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 parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.
III. 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
[[Page 32668]]
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.
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/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.
Dated: May 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12922 Filed 5-30-13; 8:45 am]
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