In an unusual move, three US Food and Drug Administration complete response letters related to manufacturing issues were announced in the same week, all relating to very different products: a gene therapy, an antibody-drug conjugate (ADC), and a prodrug/device combination.
Key Takeaways
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Rocket Pharmaceuticals stressed the limited scope of the Kresladi CRL and its alignment with senior CBER staff
The CRL for Rocket Pharmaceuticals Inc
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