Renewals – The Basics

Renewals – The Basics

Dr Marsh answers a few fundamental questions on licence renewals, with a UK slant.  For how long is my Marketing Authorisation valid? A Marketing Authorisation (MA) is granted for up to 5 years. You need to renew it at least 9 months before it expires.   Can...
Project Orbis

Project Orbis

Today we are focusing on the Project Orbis initiative, with a UK slant.   What is Project Orbis? Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) involving several other participants. The programme has been set up...