FDA Biosimilar Assessment For Sandoz Filgrastim: From ‘Same’ To ‘Highly Similar’
Agency reviewers show Oncologic Drugs Advisory Committee how analytical characterization can limit need for clinical studies.
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President-Elect Biden also adds David Kessler and Andy Slavitt to his COVID-19 response team, retains Francis Collins at NIH director.
Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.
The proposal, which would increase capacity for pandemic supplies, is similar to ideas President Trump embraced pre-pandemic.