FDA Shutdown Hangover Hurts Biosimilars, May Benefit Some ANDAs
As normal operations – and normal budget worries – resume, the agency has some meetings to reschedule.
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'Limited activities related to user fee funded programs' will continue if Congress does not pass a short-term funding measure by Oct. 1.
User-fee supported employees continue to work on pending reviews, and the lack of distractions from other tasks may help sponsors as the shutdown continues.
Though it doesn’t have a formal labeling claim, olive-oil based parenteral nutrition drug provides marketing advantages compared to soybean fat emulsions drugs, while helping to ease shortage.