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Orphan Products: US FDA Working On ‘Sameness’ Policy For Cell And Gene Therapies

 
• By Sue Sutter

Industry seeks clarity as to when a subsequent product will be judged the ‘same’ as a previously approved product that holds seven years of blocking exclusivity. CBER Director Marks says agency is working to put its views in writing soon but notes the US and EU may be headed in different directions on the issue.

Pug dogs sit on the beach in a neat row, they have the same white stripes. - Image
The same or not the same? That's the question facing the US FDA. • Source: Shutterstock

The biotechnology industry wants the US Food and Drug Administration to clarify how it will apply the concept of “sameness” for orphan product exclusivity purposes to cell and gene therapies.

The FDA’s response: We’re

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