User Fee Reauthorization: 'Pre-Conferenced' Bill Aims For Quick Passage
'Clean' bill includes expanded access language from Senate, generic review revisions from House as legislators hope for enactment this month.
You may also be interested in...
GAO says lack of clear information from FDA may influence whether manufacturers grant expanded access to investigational drugs; only two clinical holds have been due to adverse events from expanded access use.
User fee legislation headed for a US House vote this week would require pediatric studies of certain molecularly targeted cancer drugs; the requirement, which could apply to some orphan drugs, would not take effect for three years.
Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.