We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
What’s in a Name? The US Food and Drug Administration Issues a Guidance on the Non-proprietary Naming of Biological Products.
- Authors
DOLLE, Tobias; ROVNOV, Yury
- Abstract
The article reports that U.S. Food and Drug Administration (FDA) has released a guidance on non-proprietary naming of biological product to establish standards in the medical industry. Topics include impact of inconsistency in the naming conventions for biological products on international trade, cost burden on pharmaceuticals following the FDA guidance, and impact on patients' access to advanced medicines.
- Subjects
UNITED States. Food &; Drug Administration; PATENT medicines; DRUG patent laws; PHARMACEUTICAL industry; DRUG accessibility; COST
- Publication
European Journal of Risk Regulation, 2017, Vol 8, Issue 3, p559
- ISSN
1867-299X
- Publication type
Article
- DOI
10.1017/err.2017.46