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Latest From Cole Werble
Web tool to help patients find expanded access program should go live in early June, focusing initially on oncology. That timing should help deflect efforts to enact “Right to Try” legislation.
US agency's April 6 patient-focused drug development meeting on sarcopenia sent two very divergent messages about the status of measuring patient engagement on new drug development: both delivered by an unexpected messenger, former FDAer Ray Lipicky.
Experts from Prevision Policy discuss their initial impressions of Scott Gottlieb as President Trump's choice to lead FDA, his unique policy experience, what it means from the drug industry, 'Council of Elders' drug approvals, and how his selection could impact the user fee negotiations.
National Academies’ report on the fast-advancing genome-editing technologies points out that ways to improve musculature in dystrophy patients will almost certainly raise issues about treatment use in narrow population versus enhancement use in broader population. In most cases, however, specificity of genome-edited products will help limit use of the new therapies to targeted populations.
Medicaid rebates have been a fact of life in the pharmaceutical industry for 25 years. But the Affordable Care Act repeal-and-replace debate may open up the possibility of eliminating the mandatory rebates – and the requirement that all drugs be covered by the program.
Permitted speech for approved products could shift dramatically depending on how hard a Trump FDA Commissioner pushes, but the expansion at the end of the Obama Administration is a significant step in its own right – one that former Commissioner Rob Califf emphasizes in an interview that is also available as a podcast.