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GUIDANCE DOCUMENT

Rheumatoid Arthritis: Developing Drug Products for Treatment May 2013

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2013-D-0571
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The purpose of this guidance is to outline the 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 does not address nonclinical development, development of drug products for juvenile idiopathic arthritis, or development of biosimilar products.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0571.