Abstract
In this chapter I will give a brief overview of initial interactions with regulatory agencies during the development of a new therapy, for example a gene therapy product. The derivation of the rules in the United States and how gene therapy products fit into this will be described. In addition I will discuss interactions with the Food and Drug Administration (FDA), highlighting certain points to keep in mind. Finally a brief overview of European regulatory interactions for gene therapy products will also be provided.
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© 1998 Springer-Verlag Berlin Heidelberg
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Wikberg-Leonardi, R. (1998). Gene Therapy Regulatory Issues in the United States and Europe. In: Sobol, R.E., Scanlon, K.J., Nestaas, E. (eds) Gene Therapy. Ernst Schering Research Foundation Workshop, vol 27. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-03577-1_12
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DOI: https://doi.org/10.1007/978-3-662-03577-1_12
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-662-03579-5
Online ISBN: 978-3-662-03577-1
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