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Latest From Review Pathway
Overhaul of reg on how combo products are designated to review centers eliminates the reconsideration appeal, but US FDA still allows appeals up the chain of command.
Orphan Designations For Cancer Drugs: US FDA Urged To Distinguish Tissue-Agnostic From Tumor-Specific Diseases
Generic and brand firms both seem to want ‘very black and white lines’ on orphan exclusivity, but FDA isn't so sure how to distinguish biomarker-targeted disease from histologically-defined disease.
Accelerated approval would help agency monitor gene therapies for durability and off-target effects, US FDA commissioner says.
Despite putting it on hold last year, the World Health Organization is keeping its idea of biosimilar naming guidance alive. And at a recent conference it updated delegates on the pilot project for prequalifying biosimilar versions of infliximab and trastuzumab.
Although not tested in smallpox animal models, tecovirimat demonstrated efficacy in surrogate orthopoxvirus disease models in non-human primates and rabbits, FDA says; SIGA seeks approval under the 'Animal Rule' for a broad population of adult and pediatric patients, but agency notes drug's safety has not been clinically tested in children and other vulnerable populations.
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