The FDA’s very public slap of Novartis’ red face is a warning to the entire industry — don’t downplay it
In drug development, there’s an unwritten rule that the FDA can rely on the deep-pocket global players to produce clean data. The results may be positive or negative, and you’re free to interpret as you please, but the data are reliable.
All the data, from humans right down to the mice.
Trust in the integrity of the people handing over the data is essential for the current emphasis on accelerated approvals. If the top players start gaming the system, everyone can go back to the clinic and plan to plod through each standard phase of clinical trials, with a long, slow regulatory review at the end.
Remember how well that worked?
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