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FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers – 03/23/2022

Claudia Baldwin

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The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group will convene a virtual workshop on March 23-24, 1-3 PM (EST) entitled “Identification of Concepts and Terminology for Multi-Component Biomarkers”. The workshop is intended to develop multi-component biomarker concepts and terminology to identify areas of conceptual

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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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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FDA Issues Series of Guidances Under Drug Competition Action Plan

Claudia Baldwin

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CDER Statement

Original Source: fda.gov

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