Artrose: structurele eindpunten voor de ontwikkeling van geneesmiddelen

Artrose: structurele eindpunten voor de ontwikkeling van geneesmiddelen

november 5, 2019 0 Door admin

Translating…


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Docket Number:
FDA-2018-D-2896
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 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


Submit Comments

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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