Top of the morning to you, and a fine one it is. A shiny sun is hovering over the Pharmalot campus as we approach the middle of the week. After all, this is an accomplishment and a celebratory cup of stimulation is in order to help us move along. And why not? Just consider the alternatives. Meanwhile, another busy day lies ahead. On that note, here are some items of interest. Hope you have a smashing day and keep us in mind if you hear something juicy …
The effects of a federal hiring freeze on the Food and Drug Administration are unclear, but could put the agency tight spot, BioCentury opines. The agency could find itself squeezed between complying with obligations to implement new programs mandated by the 21st Century Cures Act and meeting user fee goals for drug and device reviews. Under such circumstances, the agency may let review goals slip.
Since the user fees (now over $2 million/NDA) under PDUFA were mostly used for the FDA to hire new reviewers, any hiring freeze at FDA should be accompanied by a freeze on user fees that will now not be needed, then when FDA is permitted to staff up at probably a much reduced level the user fees should be adjusted proportionately downward.
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