Emflaza's 505(b)(2) Pathway Review: Rare, But With Precedent
US FDA has relied on 505(b)(2) pathway to approve a small group of 'orphaned orphan' drugs – products without patent protection being used on an informal 'gray market' of personal importation and compassionate use protocols.
You may also be interested in...
Fresenius Kabi’s Omegaven is most recent of 13 approvals, including three with breakthrough therapy designations, where FDA has relied on real world evidence to make a regulatory decision about efficacy.
A year in our long-running series of deep dives into FDA review documents.
US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews
The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.