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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 biggest challenge for the FDA’s 10-year-old Sentinel program for post-market safety monitoring of medical products is having to deal with a wide range of partners and data sources, according to CDER Deputy Director Robert Ball. 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
The FDA issued Wuhan Chinese Moxibustion Technology a warning letter for manufacturing adulterated products, and for quality and sanitation deficiencies. 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