Summary
Is my drug or biologic eligible for one or any of the FDA expedited programs? How do I choose the right process? When do I qualify for a breakthrough? All these questions are answered during this webinar which begins with laying the foundation; first by helping you to understand what’s considered a “serious condition,” available therapies, and what defines an unmet medical need.
Goodwin Life Sciences FDA Partner Alex Varond will discuss FDA’s four expedited programs: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation, and then walk through which program is best suited to expedite and review a sponsor’s drug development and the different approaches for accelerating regulatory processes.
