‘Expanded Access’ Is Not Unfettered Access
US FDA’s updated Q&A guidance on Expanded Access places greater emphasis on safeguards around emergency use and Treatment IND programs – a change in tone from the version finalized during the ‘Right To Try’ debate.
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Expanded Access Postings Not Promotional, Unless Done In ‘Promotional Context,’ US FDA Says
Updated guidance on expanded access program clarifies that sponsors do not risk enforcement for off-label promotion if they post investigational drug expanded access policies, although that fear already may have subsided.
'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.
The Power Of The Open Public Hearing
The US FDA took three high profile applications to an external advisory committee meeting during the week of 8 May – and offered a very skeptical read on the approvability of each. All three won positive votes from the committees, in no small part thanks to the messages delivered during the Open Public Hearings.