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Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.
The US FDA’s use of outside expert advisory committees rebounded from historic lows in 2022 – but just barely. Will Commissioner Califf’s ‘update’ of the process finally mean more committee meetings in 2023?
The gene therapy firm announced that Bristol terminated a collaboration started in 2015. Nona follows its recent alliance with Moderna with a second collaboration, this time with Dragonfly.
As states weigh their options, the history of past settlements will be a factor. One state signed onto the settlement with the distributors but opted out of the deal with J&J, netting it millions more, and with faster payment, than it would have received under the national settlement.
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