Guidance on Project Orbis
Guidance on Project Orbis From: Print this page Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) to review and approve promising cancer treatments. It involves the regulatory authorities of: Australia (TGA) Brazil (ANVISA) It provides a framework for concurrent submission and review of oncology products among international partners. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies across the globe. The MHRA will participate fully in the scheme from 1 January 2021. While the FDA ser...
Source: gov.uk