Rare Disease OPEN-ing In PDUFA Possible For Drug Repurposing Advocates
OPEN ACT would provide additional six months of exclusivity when existing drugs are approved for rare diseases; congressional debate over the measure could get bogged down in drug pricing issues.
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Pediatric Cancer Study Requirements Added To FDA User Fee Bill
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.
User Fee Bill Could Become Ensnared In US Abortion Politics
Amendment defunding Planned Parenthood is one ACA repeal refugee that could hitch a ride with user fee bill, which would be 'problematic,' to say the least, for Democrats.
Orphan Drug Act: Congressional, FDA, NORD Reviews Come Amid Pricing Debate
Republican Senators request US Government Accountability Office quantify law’s impact and assess whether regulatory or legislative changes are needed. FDA plans ‘unbiased’ look at outcomes from law’s incentives, while NORD is developing data on total percentage of drug spending represented by orphan indications.