FDA wants guidance on guidances

CBER guidance documents in the works cover chemistry, manufacturing and control of products based on naturally derived proteins and on gene therapy products, as well as a guidance on monoclonal antibodies and orphan drug designation.

Xenotransplantation would be covered in another planned guidance as well as in a separate document on "Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans."...