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.
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‘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.
Comparative Claims In Product Promotions: FDA Isn’t Entirely Leaving It To Firms To ‘Duke It Out’
Four years after Woodcock’s famous comments, OPDP notes it is evaluating comparative claims as indicated in a recent untitled letter. DOJ is also looking at comparative claims. New FDA guidances are in the works, but it remains unknown when they will issue.
Passive Adverse Event Approach Is Key Facet Of US FDA's Right-To-Try Rule
Sponsors will have little obligation to conduct due diligence of adverse events experienced with right-to-try drug use under a proposed FDA rule, leading critics to once again raise safety concerns with the pathway for accessing experimental medicines. The agency will not help patients or companies determine whether drugs qualify for right-to-try.