Vinay Prasad

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FDA set to raise bar for clinical trials of CAR-T therapies

The FDA could make it harder for developers of CAR-T therapies to bring them to market by requiring full randomised controlled trials.

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Is FDA about to restrict vaccination even further?

Vinay Prasad, head of CBER, is reported to be planning to tighten regulations on vaccines after concluding that COVID-19 shots caused 10 child deaths.

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FDA unveils swift route to market for personalised drugs

FDA reveals a regulatory pathway for personalised therapies based on 'plausible mechanism', drawing on the bespoke gene-editing treatment of Baby KJ.

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Vinay Prasad returns to FDA

In a new spin on the concept of the FDA's 'revolving door', Vinay Prasad is back as head of CBER, just over a week after leaving the role.

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Vinay Prasad abruptly departs from the FDA

The disruption at the FDA continues with the departure of CBER director Vinay Prasad, less than three months after taking on the role.

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Makary, Prasad set out their vision for the FDA

Top FDA officials have spelled out their strategic priorities in the coming years, including the use of AI to "increase efficiency."

FDA set to raise bar for clinical trials of CAR-T therapies

Is FDA about to restrict vaccination even further?

FDA unveils swift route to market for personalised drugs

Vinay Prasad returns to FDA

Vinay Prasad abruptly departs from the FDA

Makary, Prasad set out their vision for the FDA

On AI and computational support of biochemistry, with Alan R...

The AI imperative: Establishing the standard for modern clin...

Vinay Prasad

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