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Pink Sheet Podcast: New Drug Submissions Lag, More US FDA Emergency Use Authorizations On The Way, BsUFA Revenue Misses Estimates

Pink Sheet Podcast: New Drug Submissions Lag, More US FDA Emergency Use Authorizations On The Way, BsUFA Revenue Misses Estimates

Source : 'The Pink Sheet'

Pink Sheet Senior Writer Derrick Gingery, Managing Editor Bridget Silverman and Executive Editor Nielsen Hobbs discuss reasons why fewer new drug applications were submitted during the first five months of 2020 and whether the trend will continue, as well as US Food and Drug Administration Commissioner Stephen Hahn’s statement that a convalescent plasma decision may be coming soon. In addition, they consider revenue and spending reductions within the biosimilar user fee program.

The End Of The FDA Approvals Boom? Fewer Applications Are A COVID-19 Consequence

Convalescent Plasma Decision May Be ‘Week Or Two’ Away, US FDA’s Hahn Says

US FDA May Grant More Emergency Use Authorizations For COVID-19 Treatments This Fall

Biosimilar User Fee Revenue Missed Estimates Again In FY 2019, Spending Reduced

By Derrick Gingery