Podcast Series: Accelerated Approvals – Introduction

Listen to the first episode of the IDDI’s Podcast series on Accelerated Approvals and learn on the latest FDA draft guidance on AA and its implications on the clinical development strategy.

Key learning objectives:

  • What is Accelerated Approvals? Meaning and purposes.
  • Clarification on the latest FDA draft guidance on accelerated approvals in oncology. 
  • Implications of AA on the clinical development strategy.

Speakers:

  • Everardo Saad, MD: Medical Director, IDDI
  • Elisabeth Coart, PhD: Director Statistical Consulting & Research, IDDI
  • Moderator: Erik Falvey, Sr. Director Business Development Europe, IDDI

Accelerated Approvals (AA) is an IDDI’s Podcast series brought to you by our leading experts in regulatory statistics and clinical development strategy. This series delves into the mechanisms behind AA, spotlighting the regulatory processes that speed up access to groundbreaking therapies and how IDDI can optimize your clinical development path and reduces time to market.