publicly available fda drug approval package informationdemonstrate H e a l t h M e d i c a l

In completing Writing Assignment #1 for RGA6212 students will have the opportunity to:

• Demonstrate an understanding of the basic principles of what encompasses safety science with respect to drug/biologics development
• Demonstrate an ability to extract and interpret safety-relevant information form the publicly available FDA Drug Approval Package Information
• Demonstrate an ability to describe/analyze safety information for an approved drug/biologic/device

For this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that is looking to develop a new, inhaled treatment for Parkinson’s Disease. Your company is very small and inexperienced and so far, none of the nonclinical safety testing or clinical testing of this new drug has begun. As your team members prepare to start nonclinical safety testing and then clinical testing of the drug, it is your task to provide your colleagues with a summary of how nonclinical and clinical data is used to inform the development of safety information about your new Parkinson’s disease drug. You also need to provide your colleagues with background information on the regulatory aspects of safety monitoring, using the safety guidance provided by FDA and ICH.

During your research to learn more about drugs that treat Parkinson’s, you discover that there is already a marketed product for Parkinson’s that is also administered by inhaler. The already approved drug is called Inbrija (also known as CVT-301 – the research code name). This is great news! You can use this similar, already-approved drug as a comparison for your investigational inhaled therapeutic for Parkinson’s.

There is a lot of information your company can learn about how to safely develop your planned novel Parkinson’s therapeutic by studying the FDA’s published NDA approval information located on the FDA’s database of approved products: