CBER

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FDA removes barriers to cell, gene therapy development

FDA wants to exert regulatory flexibility on cell and gene therapies in an effort to bring them to patients more quickly and efficiently.

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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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Tidmarsh to stand in for Prasad's role at CBER

Following Vinay Prasad's abrupt departure as CBER director, FDA has asked CDER head George Tidmarsh to take on both roles while a successor is sought.

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