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FDA makes it easier to set up US manufacturing sites

The FDA has launched a programme to make it easier to set up manufacturing facilities in the US and reduce the country's reliance on imported drugs.

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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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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.

News

FDA gives the go-ahead to restart Elevidys shipments

Sarepta has restarted distribution of its Duchenne muscular dystrophy gene therapy Elevidys, but only for patients who can walk.

R&D

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Novel study designs for rare diseases

Developing treatments for rare diseases poses many unique challenges that cannot be addressed by traditional study designs.

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Sarepta backs down and pauses Elevidys shipments

The FDA seems to have won its staring contest with Sarepta over shipments of Elevidys, as the company blinks and agrees to a pause from today.

FDA makes it easier to set up US manufacturing sites

Tidmarsh to stand in for Prasad's role at CBER

Vinay Prasad abruptly departs from the FDA

FDA gives the go-ahead to restart Elevidys shipments

Novel study designs for rare diseases

Sarepta backs down and pauses Elevidys shipments

Lilly bags FDA okay for Wegovy pill rival orforglipron

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FDA

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