publication
FDA
Preparing a Drug Registration for the US and the EU Parallel or sequential applications –…
This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the…
publication
FDA
Preparing a Drug Registration for the US and the EU: Parallel or sequential applications? –…
An overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region…
publication
FDA
US & EU Regulations for Drug Delivery Systems: development considerations for innovate products
Marielle Fournier and Anne Dupraz-Poiseau describe US and EU rules governing prefilled syringes, pen injectors and innovative drug-delivery systems for…
