Does the contact person’s signature need to be on the cover letter of the orphan drug designation request? Do you need an original signature? Can a signature page be sent separately?

An original signature of an individual representing the sponsor organization is required on one copy of the orphan drug designation request – typically the cover letter.
The original signature does not have to be the contact person. For example, the sponsor’s CEO may sign the cover letter but the individual listed as the contact person is the head of regulatory affairs.