Search Results for: COMBINATION PRODUCTS Human Factors Combination

Articles

August 29, 2019

BIOLOGICS DELIVERY - Enabling Biologic Drug Delivery of Volumes Beyond 1 mL August 29, 2019

Megan Lan, MBA, MA, and Patrick Le Gal say delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.

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.