05.17.21 Are You Ready For The FDA s Data Effect Tsunami? 8 Steps To Prepare
State-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products. Several vendors offer development-scale to commercial-scale continuous downstream chromatography systems. When adopting continuous technology, it is critical to demonstrate that continuous downstream processes are comparable to batch-mode downstream processes and provide the supporting comparability data for technical and business decisions. Access the case study to learn more.
Featured Editorial
By Matt Collins, Cignyl, and John Giantsidis, CyberActa, Inc.
The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan. Why is this a tsunami? Because you ll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more! He
01.06.21 X4 Pharma Adjusts Clinical Trials For A COVID-19 World
The goal of this report is to help readers stay on top of trends such as the use of challenge trials, diagnostic development, and how companies are responding to the COVID-19 pandemic. Over 130 Phase 1 decision-makers were surveyed to share insights into where the Phase 1 market is now and what changes they expect over the next four years. Click here to learn more.
Featured Editorial
By Ed Miseta, chief editor, Clinical Leader
With the COVID-19 pandemic afflicting patients around the world, those with a compromised immune system are at even greater risk. X4 Pharma is currently conducting a global Phase 3 trial that was already underway when the pandemic hit and concerns patients who are immunocompromised.