Osteoarthritis: Structural Endpoints for the Development of Drugs August 2018
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter 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
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:
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.