quality, case studies global regulatory partners

FDA Guidance on Substantial Evidence of Effectiveness for Drugs and Biologics

OVERVIEW Companies developing novel drugs or biologic products for rare diseases or other life-threatening diseases can now plan clinical studies for Investigational New Drugs (INDs) to establish their drug or biologic candidate’s effectiveness and explore strategies reduce to their time to market with New draft guidance from FDA. GUIDANCE: ‘Providing Evidence of Effectiveness of Human Drug …

FDA Guidance on Substantial Evidence of Effectiveness for Drugs and Biologics Read More

Scroll to Top