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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Acting Commissioner Giroir Emphasizes 'Transitional' Period, Suggesting Time At US FDA Will Be Short
Giroir's memo to FDA staff also says intends to coordinate with prior acting commissioner Norman Sharpless to ensure current activities continue.
Now most, if not all, assessment divisions within the Office of New Drugs have dealt with issues surrounding small trials and rare diseases, defying common belief that experience was spread unequally.
Orphan drugs and priority reviews achieved historic highs in CDER's 2018 novel approval class, but share of products with breakthrough therapies took a slide.