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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FDA Shutdown Plans For 2015: Same As 2013, But With More People
'Limited activities related to user fee funded programs' will continue if Congress does not pass a short-term funding measure by Oct. 1.
Shutdown Week Two: Could Sponsors Find A More Focused FDA?
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.
Baxter’s Clinolipid Could Offer Safety Advantages While Mitigating Shortage
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.