September 1, 2022
The Inchstone Project submits comments to the FDA draft guidance on “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.”
The comments are one of The Inchstone Project's main initiatives during the first year of the inauguration
The Food and Drug Administration draft guidance emphasizes several critical aspects of Clinical Outcome Assessments (COA) development and selection. The Inchstone Project’s suggestions highlight these aspects and other elements related to the exceptional circumstances of rare diseases and severely affected Developmental Epileptic Encephalopathies (DEEs). The Project also drew on the 2019 Guidance on Rare Diseases.