A single product candidate that provides clinical benefit across multiple indications and patient populations allows more conditions to be treated quicker, resulting in more efficient research and development for sponsors. However, developing these types of products is not without its challenges. Sponsors that strategically plan for Investigational New Drug (IND) management can maximize limited resources, simplify activities surrounding IND maintenance, and ensure IND holders comply with required responsibilities.
In this white paper, you will learn:
- Benefits of consolidating general information into one place and aligning dates to streamline reporting
- Pediatric requirements to consider early in the development process
- Possible labeling scenarios and requirements
- Opportunities for accelerating development and eventual approval
How COVID-19 Has Impacted Regulatory Operations: A Conversation with PRA’s Regulatory Operations Team
COVID-19 impacted all areas of our lives over the past year. We caught up with the Regulatory Operations team to see how working from home,…