Senate Prevails On PDUFA Antibiotic Incentive As House Vote Nears
This article was originally published in The Pink Sheet Daily
House is expected to vote on the reconciled FDA user fee bill June 20. Negotiators picked Senate GAIN language, including its less prescriptive qualifying pathogen definition.
You may also be interested in...
Durata has post-marketing requirements to continue resistance-related studies, but its label includes stewardship language similar to other antibiotics.
In letters to congressional leaders, generic drug trade group outlines six proposals that it says would save the government billions of dollars and lessen the impact of sequestration cuts.
Industry presenters tell FDA a broad list of potential diseases will attract more developer interest, but advocacy groups push for more targeted criteria during a public hearing on the new exclusivity incentive.