2016 National Healthcare Quality and Disparities Report

whitePaper | May 25, 2023

CDER’s mission is to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients. To advance this mission, FDA’s Pharmaceutical Quality for the 21st Century Initiative promotes an efficient, agile, and flexible pharmaceutical manufacturing sector that reliably produces quality drugs without excessive regulatory oversight.

whitePaper | December 5, 2022

Serialisation has emerged as a complex challenge for the pharmaceuticals sector which is facing a multiplicity of differing regulations that vary from one country to another.

whitePaper | March 28, 2023

About 70% of new chemical entities (NCEs) are highly insoluble.1 It’s a fact that troubles small biotechnology companies and other drug manufacturers. Indeed, insoluble drugs present a wide range of challenges during development and, if not addressed, can ultimately render drugs ineffective in patients.

whitePaper | May 23, 2022

The world’s scientific data today is a morass. 50-80% of research scientist and data scientist time is spent wrestling with data before they can focus on highervalue AI/ML and advanced analysis to help bring new life-saving therapeutics to market.

whitePaper | November 8, 2022

While drugs and devices differ in their development, clinical trial phases and regulatory guidelines, the most important difference is that medical devices do not achieve their principal action by pharmacological means.

whitePaper | August 8, 2022

Biopharma R&D professionals generally admit that the current "high-cost, high-risk" development model is unsustainable. Despite technological.