FDA Can't Win On Guidances: Expanded Access Policy, Duchenne Worries Collide
Keeping guidances in draft form makes Congress angry, but finalizing them gives Wall Street the vapors.
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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.
Agency should issue statement that deaths occurring during compassionate use will not automatically penalize a drug's development, ethicists from NYU Langone Medical Center say.