The U.S. Food and Drug Administration released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix.
Simplifying Global Compliance
U.S. FDA Proposes Naming Convention for Biosimilars, Reference Products
International Pharmaceutical Regulatory Monitor
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International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.
PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.
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International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.
PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.
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