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

 
• By Derrick Gingery

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

FDAEntrance_1200x675
The FDA may not be adequately communicating its rare disease flexibility policy to sponsors in official documents. • Source: File photo

More from Approval Standards

More from Pathways & Standards