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Providing Regulatory Submissions in Electronic Format — Standardized Study Data

Claudia Baldwin

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FDA Approves Neoadjuvant Nivolumab and Platinum-doublet Chemotherapy for Early-stage Non-small Cell Lung Cancer

Claudia Baldwin

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

Original Article: fda.gov

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Data Standards Program Strategic Plan and Board

Claudia Baldwin

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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.

Original Source: fda.gov

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CTTI and FDA Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials – 03/18/2019

Claudia Baldwin

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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.

Original Post: fda.gov

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