Company thinks gel formulation, Special Protocol Assessment with FDA improve its chances for success.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Insurance trade groups warned that the Big Beautiful Bill destabilize Medicaid and result in the largest ever roll-back in health care coverage in the US.
Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
