FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer

The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.

On March 18, 2019, the Clinical Trials Transformation Initiative (CTTI) and FDA held a public workshop, “Enhancing the Incorporation of Patient Perspectives in Clinical Trials.” This workshop met an FDA commitment that is part of the sixth authorization of PDUFA VI.