News & Insights

Biologics Consulting is thrilled to announce

A new guidance from FDA last month may be adding to confusion in industry regarding the difference between FDA requirements and programs that are voluntary.  At first glance, the title "Qualification Process for Drug Development Tools" might suggest that the FDA has new expectations for sponsors planning…

Given the numerous inquiries from prospective sponsors interested in conducting clinical trials for COVID-19 products, FDA has issued new guidance to assist sponsors in preparing Type B pre-investigational new drug application (pre-IND) meeting requests for COVID-19 related drugs and biologics1. This…