Just for reference, the FDA occasionally takes Big
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Posted On: 02/10/2022 3:51:37 PM
Just for reference, the FDA occasionally takes Big Pharma behind the woodshed for a good lashing as well as us:
"But the panel’s concerns were largely overshadowed by FDA officials tearing into Lilly over not making good on its promises to increase trial diversity, submitting the application without consulting regulators before the trial concluded and misrepresenting interactions with the agency during its presentation."
"Discussion soon devolved into a public flogging, however, with Pazdur and Singh taking Lilly to task over not just the diversity issues, but the nature of the study itself [regarding the choice of] primary endpoint...
The panel's big conclusion was don't trust trials conducted only in China.
https://enewspaper.latimes.com/desktop/latime...000fdcfd8b
"But the panel’s concerns were largely overshadowed by FDA officials tearing into Lilly over not making good on its promises to increase trial diversity, submitting the application without consulting regulators before the trial concluded and misrepresenting interactions with the agency during its presentation."
"Discussion soon devolved into a public flogging, however, with Pazdur and Singh taking Lilly to task over not just the diversity issues, but the nature of the study itself [regarding the choice of] primary endpoint...
The panel's big conclusion was don't trust trials conducted only in China.
https://enewspaper.latimes.com/desktop/latime...000fdcfd8b
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