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FDA Commissioner Scott Gottlieb issued a statement Tuesday highlighting what the agency would do with the increased funds provided in the administration’s proposed budget for FY 2019. Read More
The legislation would allow the NIH more flexibility to collaborate with companies developing innovative technologies aimed at addressing the opioid crisis. Read More
Sponsors of drugs for treatment of bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer should use complete response rates in carcinoma in situ patients as their primary endpoint, the FDA said in a final guidance that is not significantly different from the agency’s 2016 draft. Read More
The letter claims that right-to-try legislation does not bring about policy changes that would afford patients greater access to promising investigational therapies. Read More
Brand-name drugs referenced by generics covered by the new guidance include fungal infection treatment, ADHD treatment and Aleve-D Sinus & Cold. Read More
The Council of Economic Advisers issued new recommendations for reducing drug pricing, including changes in government policies and regulations, such as moving Medicare Part B drug coverage into Part D. Read More
The budget deal approved by lawmakers in the early hours on Friday raised caps on non-defense discretionary spending by $63 billion in fiscal 2018 and $68 billion in fiscal 2019, but FDA appropriations remain unclear. Read More
A bipartisan group of members of the Senate Health Committee introduced a bill to increase National Institutes of Health research into non-opioid pain treatments. Read More