Zdrowie i gospodarka · 28/11/2006

FDA Announces Final Guidance for Gene Therapy Clinical Trials on Observing Subjects for Delayed Adverse Events

The Food and Drug Administration (FDA) has released a final guidance document providing recommendations for collecting data on delayed adverse events in gene therapy study subjects, finalizing a draft from August 2005 and supplementing a previous guidance on retroviral vector testing, both dated November 2006.