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Day: February 20, 2025

Should You Delay Your Submissions if Your FDA Review Team Got Fired?

April 4, 2025February 20, 2025 by iwewlkws

What if the people involved in the review of your application at the FDA got fired? It is not an anecdote but the reality that hit several companies last week. What is expected from the sponsors working with those individuals who are no longer employed by the FDA? It’s a tough question. There are some … Read more

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Will FDA’s Political Vulnerability Influence What New Drugs Are Approved?

April 4, 2025February 20, 2025 by iwewlkws

The kind of cuts in its workforce and major policy changes that the FDA has seen in the last month, it did not see in its entire 100-plus-year history. This, in turn, has exposed what the FDA was always accused of; being a strongly politically-influenced organization that is not as independent as it claims. But … Read more

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