Zdrowie i gospodarka · 09/09/2021

FDA Releases Draft Guidance on Nonclinical Biodistribution Considerations for Gene Therapy Products

The US Food and Drug Administration (FDA) has released a draft guidance for the pharmaceutical industry on nonclinical biodistribution considerations for gene therapy products, developed under the International Council for Harmonisation (ICH). The guidance aims to promote harmonized recommendations for nonclinical biodistribution studies and facilitate more efficient development of gene therapy products while minimizing animal use.