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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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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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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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First Generic Drug Approvals

Claudia Baldwin

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Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients. “First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States.

Original Article: fda.gov

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