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The FDA has advised sponsors of gene therapy products that incorporate human genome editing (GE) on how best to communicate with the FDA about products in development in a draft guidance released yesterday. Read More
The European Medicines Agency (EMA) is seeking comments from the public on a draft pharmacovigilance guideline published yesterday on assessing the risk of drug-related fetal abnormalities and when to employ a pregnancy prevention program (PPM) or risk minimization measures (RMM). Read More
Three Democratic representatives from the House Committee on Oversight and Reform sent a letter to the Treasury Department and the Department of Justice (DOJ) Monday, expressing their alarm at certain companies claiming tax benefits from their opioid settlement expenses. Read More
Despite the fact that many states have lifted their mask mandates and the last surge of a COVID-19 variant of concern peaked several weeks ago, we are nowhere near public health officials announcing the end of the public health emergency, according to epidemiologists who track COVID-19. Read More
“The evidence shows antibiotics are not needed by most children and young people with middle ear infections,” said Paul Chrisp, director of NICE’s Center for Guidelines. Read More
Grassley introduced proposed legislation last year that would require the FTC to report to Congress on possibly anticompetitive prescription drug-pricing practices. Read More