US FDA Should Offer Formal Declaration Of Orphan Drug Flexibility, Attorney Says

Attorney Frank Sasinowski says the agency should include new "boilerplate language" in official documents describing scientific flexibility for orphan drug approval requirements.

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The FDA may not be adequately communicating its rare disease flexibility policy to sponsors in official documents. • Source: File photo

US Food and Drug Administration officials rarely shy away from an opportunity to trumpet the flexibility they allow with rare disease approval standards.

The FDA has approved drugs despite not having two adequate and well-controlled trials, as is usually required for conventional drugs,...

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