FDA issues guidance on cancer clinical trial eligibility, recommending evidence-based laboratory criteria to reduce unnecessary exclusions in oncology studies.

FDA issues new guidance on cancer clinical trial eligibility, recommending broader inclusion of patients with ECOG PS2 and KPS 60–70 performance status.

Discover the new FDA guidance on oncology trial eligibility criteria, risk-based washout periods, and concomitant medication management for clinical studies.

The FDA has released a major update to its Bioequivalence Statistical Guidance, replacing the 2001 version. The new document introduces adaptive designs, modern statistical methods, guidance for highly variable drugs, NTI products, missing data handling and model-based approaches for generic drug development.

The FDA has released the March 2025 edition of the "Study Data Technical Conformance Guide", an essential document for ensuring regulatory compliance in the submission of standardized data in clinical studies. The new guidelines affect processes such as INDs, NDAs, ANDAs and BLAs, ensuring that manufacturers follow the standards of the FDA Data Standards Catalog. Compliance with these rules is key to avoiding delays and guaranteeing acceptance of electronic submissions to CDER and CBER.