US FDA commissioner tells House committee that culture changes – and label changes – are among the actions the agency is pursuing to address the opioid crisis.
Hard policy changes by themselves won't be enough to combat the opioid epidemic, US FDA Commissioner Scott Gottlieb says, calling for the agency to facilitate a culture change around medications used for addiction recovery.
Testifying before the House Energy and Commerce Committee Oct. 25 on federal efforts on fighting the opioid crisis, Gottlieb announced...
Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion
Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
