The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Draft Guidance on Cell, Gene Therapy Products Establishes General Framework

    The US Food and Drug Administration (FDA) has release a new draft document aimed at providing guidance on the preclinical assessment of cellular, tissue and gene (CTG) therapy products. CTGs are essentially used to make therapeutic changes to a person's cells, tissue or genes by injecting a patient with altered DNA, cells or implanted with organs. The products include cellular therapies, gene therapies, therapeutic vaccines, xenotransplantation and other drug products, i...