House Credit for FDAAA
This article was originally published in RPM Report
Key House staffers on the Food & Drug Administration Amendments of 2007 are identified. Key negotiators for FDA and the biotech industry on the failed follow-on biologics effort are also identified.
You may also be interested in...
An abbreviated pathway for follow-on biologics just missed getting tacked onto the FDA user fee/drug reform legislation. It will be years before proponents get another shot at creating an abbreviated approval pathway for the biotech copycats. So who won and who lost?
Key figures involved in the EPO safety debate from FDA and CMS; the Zimulti advisory committee review; and the Senate drafting of the FDA legislation.
Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.