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GUIDANCE DOCUMENT

Osteoarthritis: Structural Endpoints for the Development of Drugs August 2018

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-2896
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research

The purpose of his guidance is to assist sponsors who are developing drugs, devices, or 20 biological products (medical products) to treat the underlying pathophysiology and structural progression of osteoarthritis (OA).2 21

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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-2018-D-2896.

 
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