Martin Makary

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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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FDA releases previously unseen CRLs in transparency push

The FDA's earlier decision to publish complete response letters was largely a repackaging of existing information, but now it has gone much further.

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Just how radical is the FDA's complete response letter move?

The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.

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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."

News

CDC stops backing COVID jabs for pregnant women, children

In a new sign of downgraded support for COVID-19 shots by the US administration, the CDC has stopped backing vaccines for pregnant women and children.

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Call goes out for feedback on US health deregulation

The Trump administration wants the public to join in the effort to cull redundant health regulations as part of its '10-for-one' deregulation policy.

FDA unveils swift route to market for personalised drugs

FDA releases previously unseen CRLs in transparency push

Just how radical is the FDA's complete response letter move?

Makary, Prasad set out their vision for the FDA

CDC stops backing COVID jabs for pregnant women, children

Call goes out for feedback on US health deregulation

NHS staff 'feel unprepared for digital transformation'

How to meet your physicians where they are online

Martin Makary

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