FDA Oversight By House To Focus On User Fees, Compounding Law
This article was originally published in The Tan Sheet
Among the Energy and Commerce Committee’s priorities are ensuring correct implementation of the generic drug and biosimilar user fee programs, whose launches have experienced some hiccups.
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Guidance is “emerging” that will allow sponsors to use data from products not licensed in their respective regions in applications.
Members will enter data into secure database, allowing trade groups to gauge trends and problems with the PDUFA V application review program – and giving industry a stronger negotiating position for the next user fee round.
Teva is the first company to get FDA approval of a version of Amgen’s Neupogen; one biosimilar expert questions why Teva did not switch its BLA to a biosimilar application when that pathway became available.