STAT Plus: FDA and counterparts in Canada, Australia to collaborate on cancer therapy reviews

In an effort to speed the process of getting drugs to patients around the world, the Food and Drug Administration and its counterparts in Canada and Australia on Tuesday unveiled a new pilot program that will allow the agencies to review — and potentially greenlight — cancer therapies at the same time.

Typically, drug companies have to endure the regulatory process in each country separately and will often submit applications to the agencies at different times. Under the new effort, dubbed Project Orbis, companies can file their applications to FDA, Health Canada, and the Australian Therapeutic Goods Administration and the authorities will review them concurrently and collaboratively.

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