Comparing supplemental indications for cancer drugs approved in the US and EU

Cancer drugs initially granted regulatory approval for one disease may also prove useful in treating other diseases. In these cases, manufacturers may seek to add supplemental indications to their drug labels. The extent to which manufacturers seek supplemental indications for cancer drugs may diffe...

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Veröffentlicht in:	European journal of cancer (1990) 2024-11, Vol.212, p.114330, Article 114330
Hauptverfasser:	Stoelinga, Jelle, Bloem, Lourens T., Russo, Massimiliano, Kesselheim, Aaron S., Feldman, William B.
Format:	Artikel
Sprache:	eng
Schlagworte:	Accelerated approval Antineoplastic Agents - therapeutic use Conditional marketing authorisation Drug Approval Drug Labeling EMA European Union FDA Humans Neoplasms - drug therapy Rare disease designation Retrospective Studies Supplemental indications United States United States Food and Drug Administration
Online-Zugang:	Volltext
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