FDA draft benefit-risk assessment guidance - a cancer treatment perspective
On September 29, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance for the industry entitled "Benefit-Risk Assessment for New Drug and Biological Products" to clarify how...
Five challenges in obtaining strong feedback from clinical trials and ways to overcome them
When pharmaceutical companies have completed a clinical trial, they may want to organise a result meeting with the attendance of participating...
The value of generating early insights on your investigational drug
When pharmaceutical companies develop new medicines, they are required to comply with regulatory requirements by reporting and publishing their clinical results. Adhering to these...