We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
House Republicans’ $1.51 trillion tax reform bill released Thursday would repeal the orphan drug tax credit, which currently allows drug manufacturers to claim a credit equal to 50 percent of the costs of any human clinical testing done for a product in a rare disease, as defined by the FD&C Act. Read More
The Centers for Medicare and Medicaid Services reduced the amount Medicare Part B will pay hospitals for purchasing drugs through the 340B discount program — cutting reimbursements down to the average sales price minus 22.5 percent, rather than the previous ASP plus 6 percent — for the 2018 calendar year. Read More
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, a high-ranking agency official told an FDAnews regulatory conference. Read More
The FDA updated its guidance on communications with generics manufacturers to reflect the timelines agreed to in the second generation of the GDUFA program, which took effect Oct. 1. Read More
GAO researchers found that medication-assisted treatment can be more effective in reducing opioid use and reducing program dropouts than abstinence-based treatment. Read More
The European Medicines Agency revised its 2009 guideline on developing treatments for axial spondyloarthritis, accounting for changes in clinical practice. Read More
A multistate price-fixing lawsuit against generic drugmakers should be dramatically expanded to target more drugs, more companies and, for the first time, individual company executives, the attorneys general who filed the litigation told a federal court. Read More