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Articles

April 1, 2019

RISK MANAGEMENT - FDA’s Quality Risk Management Approach to New Drug Applications April 1, 2019

Kaiser J. Aziz, PhD, explains how the FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.

August 27, 2018

DRUG DEVELOPMENT - Cell & Gene Therapies Calling for Innovation in Drug Development August 27, 2018

Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.

March 29, 2016

DRUG DEVELOPMENT - Don't Overlook Key Preclinical Research March 29, 2016

Robert Wenslow, PhD, and Ann Newman, PhD, believe too often, drug discovery scientists, material scientists, and formulation specialists work in silos throughout the drug discovery process. Better integration of their efforts can reduce drug development schedules, risk, and overall costs that provide direct competitive business advantages.