FDA

News

The US launches a concerted effort to "restore American leadership in clinical trials" as it deals with the emergence of China as a global R&D hub.

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Shares in uniQure have rocketed this morning, as it emerges that the FDA will not require it to run a new trial of Huntington's gene therapy AMT-130.

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The FDA has laid out a framework to use 'prior knowledge' on manufacturing, non-clinical, and clinical data to support cell and gene therapy filings.

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The turmoil at the FDA continues with the news that Tracy Beth Høeg has been fired as acting head of CDER, to be replaced by Michael Davis.

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According to multiple press reports citing anonymous insider sources, Dr Marty Makary has resigned after a year at the head of the FDA.

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Marty Makary's position as FDA Commissioner is said to be in jeopardy, raising the threat of further chaos at the agency if he is ousted.