FDA Taps First 'Breakthrough' Product As Stakeholders Propose Criteria

FDA Taps First 'Breakthrough' Product As Stakeholders Propose Criteria-insidehealthpolicy.com: FDA recently made its first breakthrough drug designation but is still grappling with how sponsors will utilize the expedited development pathway that was created as part of the recently enacted FDA Safety and Innovation Act, agency officials revealed this week. The revelation came as stakeholders this week proposed qualitative criteria the agency could use to evaluate eligibility for the new designation and categories of drugs that could qualify for the expedited development pathway.