FDA's Guidance on Demonstrating Effectiveness: The Importance of Adequate Clinical Investigations and Confirmatory Evidence
The FDA has released a draft guidance for industry titled "Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence," which complements previous guidance documents. The guidance aims to provide clarity on how one clinical investigation and confirmatory evidence can meet the substantial evidence requirement for demonstrating effectiveness of drugs and biological products.