• Regulatory NewsRegulatory News

    Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic

    Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market. Background As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced in August that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-n...
  • Regulatory NewsRegulatory News

    Senate Investigation Blames Superbug Outbreaks on Poor FDA Oversight

    A Senate report released Wednesday finds that the US Food and Drug Administration's (FDA) post-market surveillance system for tracking medical devices is ineffective. The report found systemic issues related to device oversight and reporting, which contributed to at least 25 superbug outbreaks linked to closed-channel duodenoscopes that infected some 250 patients in the US and Europe between 2012 and 2015. Duodenoscopes made headlines in early 2015 after Carbapenem-resi...