Ruxandra Teslo in The New York Times:
Before a new therapy can be tested in people in the United States, its sponsor must file what is known as an Investigational New Drug application. The submission can run to hundreds and even thousands of pages and includes extensive detail on manufacturing processes and quality controls, much of it designed with later commercial production in mind. What Australia does instead is focus on the questions related to evidence that the therapy is safe, which is what matters most in an early human study.
The result of the Australian system is that much-needed drugs are available faster to patients. Australia can cut up to nine months from the timeline before the application to start a trial is submitted, and another three to six after that. For a biotechnology company spending $2 million per month, this gap can be the difference between surviving and folding.
More here.
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