J&J's Compassionate Use Advisory Cmte. May Become Industry Model
NYU School of Medicine-led pilot program – created to evaluate requests for pre-approval access to Janssen's multiple myeloma drug Darzalex – blinds requests and evaluates them according to set of guiding principles.
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Pharma Industry Broadens Its Approach To Expanded Access
Novartis co-leads industry forum on preapproval access that aims to share best practices and engage patient groups; Janssen is launching three pilots to leverage collection of preapproval access data.
FDA Policy Says Right-to-Try Talks Are Between Providers, Sponsors
New internal policy says the US agency cannot force a drug maker to supply an unapproved drug to a patient for expanded access and that the provider must seek company approval to provide the product.
'Right To Try' Or 'Right To Ask'? Hearing Spotlights Adverse Events As Key Barrier To Expanded Access
FDA and the pharmaceutical industry appear to have a shared interest in finding ways to dramatically increase expanded access programs to avoid a potentially difficult fight over 'Right to Try' legislation at the federal level in 2017. A September 22 hearing on a pending Senate bill illustrates why.