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ACRP 2019 OnDemand

210 - Understanding Regulatory Guidance for Gene Therapy Development


Apr 14, 2019 11:30am ‐ Apr 14, 2019 12:30pm



Credits: None available.

Non Member: $75.00
Members: $15.00

Description

It has been a big year for gene therapy. In the past 12 months, three gene therapy products received approval from FDA. In July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy. The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products. In this presentation, Dr. Vaughn will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for clinical development of new gene therapy products.

Learning Objectives:

  • Identify the six new draft guidance documents recently released by the FDA in the area of gene therapy.
  • Understand the basic recommendations the FDA has for sponsors and researchers working in the area of gene therapy.
  • Describe general differences between the development of gene therapy products and traditional pharmaceutical products.

Speaker(s):

Credits Available


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