• FDA: Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations

    14 days ago - By Gene Therapy

    Posted on: 13 October 2021,
    This guidance provides FDA's current thinking on determining sameness of human gene therapy products under FDA's orphan drug regulations for the purpose of orphan-drug designation and orphan-drug exclusivity.
    {loadposition user9}
    Read more ...