FOBs Help Wanted: Waxman Appeals To Obama
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA should start approving follow-on biologics even in the absence of legislation, House committee chairman tells president in bid to increase his negotiating leverage.
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FOBs: White House Says 7 Years Of Exclusivity Is "Generous Compromise"
Rep. Henry Waxman, D-Calif., probably had a pretty good moment at his mailbox last week: he got a 1letter from the White House essentially endorsing his approach to follow-on biologics
FOBs: White House Says 7 Years Of Exclusivity Is "Generous Compromise"
Rep. Henry Waxman, D-Calif., probably had a pretty good moment at his mailbox last week: he got a 1letter from the White House essentially endorsing his approach to follow-on biologics
Follow-On Biologics: White House Calls 7 Years Of Exclusivity A "Generous Compromise"
Reply to Rep. Waxman notes that "a serious review of FDA's existing authorities is underway."