Vinay Prasad | pharmaphorum

Saturday 28 February 2026

Vinay Prasad

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Scrabble lettering of Two and One on grass

Makary says FDA will "end two-trial dogma" for approvals

The FDA plans to adopt a new policy that will do away with the default requirement to base regulatory filings for new medicines on two pivotal trials.

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

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?

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 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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revolving door

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

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.