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Could Revisiting US Approval Decisions Become Less Rare?

 
• By Derrick Gingery

While not identifying specific situations raising potential questions, the FDA commissioner uses his appearance at agency's annual rare disease event to advise regulatory decisions may be revisited as more data becomes available. 

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FDA Commissioner Stephen Hahn said approval speed does not have to be sacrificed to maintain safety and efficacy standards. • Source: File photo

Commissioner Stephen Hahn advised rare disease stakeholders that the US Food and Drug Administration will continue reviewing data as it emerges, including information on approved drugs, and could adjust earlier decisions if warranted.

His comments do not represent any reversal of existing FDA policy. For example, among the regulations governing accelerated approval is the ability to revoke a product's clearance based on a...

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