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Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regulatory’ Requirements

 
• By Brenda Sandburg

Vanda says FDA improperly requires it to disprove all alleged deficiencies in its Hetlioz application for jet lag. Contentious approach to notice of opportunity for hearing contrasts with that of Intarcia and Lexicon, which also seek hearings over FDA’s proposal to refuse their applications.

Hearing
Vanda criticizes FDA's notice of opportunity for hearing process • Source: Shutterstock

Vanda Pharmaceuticals, Inc. sharply criticized the US Food and Drug Administration’s “notice of opportunity for hearing” procedure while arguing that the agency must begin a hearing next month on its refusal to approve a supplemental new drug application for Hetlioz.

The agency announced in an 11 October Federal Register notice that it is proposing to refuse the application to add...

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