2013-12922. Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Rheumatoid Arthritis: Developing Drug Products for Treatment.”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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 30, 2013.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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 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.