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I think this is the key section: _"It’s not just speed. The FDA also is approving more drugs, hitting a record 59 new therapies in 2018. Almost three-fourths r
by caseysoftware 7y ago
I think this is the key section:
_"It’s not just speed. The FDA also is approving more drugs, hitting a record 59 new therapies in 2018. Almost three-fourths received a priority review. That, combined with more efficient data collection, is responsible for the faster FDA action, said Aaron Kesselheim, a professor at Harvard Medical School. Companies are also communicating earlier and more often with the agency, which can head off issues at preliminary stages and help them get products through on the first attempt, he said."_
So as in any field, better communication with stakeholders improved the process and eliminated some issues earlier.
Then, better data collection helps them evaluate studies better. I bet it also reduces the back and forth and the "what does this mean" aspect of the studies after.
And then companies can pay for expedited evaluation.. which if they've been communicating clearly all along and have better data, doesn't seem far fetched.
The next thing you know, someone will suggest clear planning with stakeholders, code reviews, and unit tests will improve code quality and even ship dates! But that may be crazy talk.