Articles tagged with “fda-oncology”

Project Orbis: Oncology Drug Review & Global Expansion

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

30 min read

2/28/2026

project orbis fda oncology regulatory affairs drug approval process global harmonization concurrent submission clinical trials regulatory science

Project Orbis: Concurrent Oncology Drug Review Process

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

35 min read

2/28/2026

project orbis fda oncology regulatory affairs concurrent review cancer drug approval global regulatory submission oncology center of excellence

Project Orbis Impact: Analysis of Cancer Drug Review Times

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.

25 min read

2/28/2026

project orbis fda oncology regulatory affairs drug approval timeline concurrent submission global regulatory strategy cancer drug access swissmedic data