Articles tagged with “project-orbis”

Examine the UK MHRA drug approval process, covering Marketing Authorisation, the International Recognition Procedure (IRP), and post-Brexit regulatory pathways.

Explore Project Orbis, the FDA's global oncology review framework. Analyze approval timelines, partner agencies, and challenges in expanding beyond cancer.

Explore Project Orbis, the FDA framework for simultaneous oncology drug review. Understand how international partners coordinate to reduce approval delays.

Examine Project Orbis data on FDA oncology approvals. Analysis shows concurrent review reduced submission gaps to 33 days and accelerated access by 2.6 months.