FDA has issued draft guidance on potency assessment of active immunotherapy products, covering potency assays, critical quality attributes, bioassays, physicochemical assays and product-specific considerations.

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.

FDA CBER has updated SOPP 8704 on MDUFA user fee payments and billing activities, including electronic payments, payment verification, user fee holds, refunds and establishment registration fees.

FDA updates SOPP 8212 on breakthrough therapy designation. Key changes in timelines, communication, and lifecycle management for manufacturers.

FDA releases SOPP 8412 Version 10 detailing labeling review procedures for drugs and biologics under BLA, NDA, and ANDA pathways.

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.