返回 Agenda
Breakthrough Designation and Expedited Approvals
Session Chair(s)
Lisa Ambrosini Vadola, PhD, MA
Manager, Medical Writing
Whitsell Innovations, Inc., United States
FDA offers several expedited approval programs to facilitate rapid and effective review of New Drug Applications for therapies treating serious medical conditions that represent an unmet need. Introduced in 2013, Breakthrough Therapy Designation (BTD) is the most recent addition to FDA’s expedited approval pathways and has since been highly sought after by sponsors for therapies across a variety of serious conditions. In this session, we will present an overview of BTD and other expedited approval pathways and you will learn best practices for crafting successful applications for these designations.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Define FDA’s expedited approval pathways and their application
- Recognize the requirements in a BTD application
- Employ medical writing best practices in the drafting of a BTD application
Speaker(s)
Speaker
Lima Chutkan, PhD, RAC
Alnylam Pharmaceuticals, United States
Associate Director, Medical Writing
Speaker
Karen Moretti, MS, MSc, RAC
Pfizer, United States
Oncology Therapeutic Area Lead, Medical Writing Submissions