Measuring Pharmaceutical Quality through Manufacturing Metrics and Risk-Based Assessment

whitePaper | July 4, 2023

The past two decades have witnessed transformative changes in our approach to using modeling & simulation to assess and manage DDIs. Multidisciplinary innovations in mechanistic assessment of absorption, distribution, metabolism, and excretion (ADME), population pharmacology and pharmacogenetics.

whitePaper | March 10, 2023

This pharma messaging guidebook features 20 proven cognitive science techniques that can be used to optimize pharmaceutical claims and messages.

whitePaper | June 22, 2022

The technologic and pharmacologic advances that have enabled researchers to take aim at previously untreatable diseases have contributed to an increase in the number of molecules in the development pipeline that are challenging and difficult to manufacture.

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 | June 27, 2022

As the world begins its transition into a postpandemic existence, it becomes possible to look back on the past two years and begin to quantify the effects that COVID-19 has brought.

whitePaper | June 22, 2023

Generic medicines are the backbone of the U.S. prescription drug market, supplying more than 9 out of every 10 prescriptions. And the availability of generic medicines overall is remarkably stable even during challenges such as the COVID-19 pandemic.