Nomination Summary for DNA-based products (N99020)
Nominated Substances: Adenoviral vector (hGH), Adenoviral Vector (AdhAQP1), DNA-based products
Nomination Date: 05/19/1999
Nominator: FDA
Rationale: To assess safety concerns of DNA-based products such as 1) persistence and integration into the host's genome, 2) distribution to gonadal tissue, and 3) ectopic protein production and abnormal immune activation.