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New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.
US FDA's staff have sometimes worked late into the night to help sponsors meet deadlines and avoid errors in responding to a notice of violation. As is often the case, early communication helps avoid problems.
The center is partnering with Obsidian to make autologous TILs work better after being infused back into patients by using IL-15, which may be less toxic than the high-dose IL-2 currently used.
Agency cites video promoting Biohaven’s Nurtec ODT, which first aired on ABC’s TV show The View, for misleading comparative claims, inadequate display of risk information, and failure to submit promo for review.