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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