1. New Growth Industry in Human Growth Hormone?
2. Commercial Biotechnology: An International Analysis, US Congress, Office of Technology Assessment, Washington DC, January 1984, OTA-BA-218. The report is archived at: www.princeton.edu/â¼ota/ns20/topic_f.html (accessed 16 November 2009) and there is an extensive chapter on the use of the technology for the production of pharmaceuticals including hGH.
3. Public Health Service Act § 351 provides the legislative authority for the regulation of biological products and this is distinct from the Federal Food Drug and Cosmetic Act that gives FDA the authority to regulate drugs. Despite these two differing regulatory authorities, FDA uses the same standard for therapeutic and safety evaluation.
4. 21 Code of Federal Regulations Part 600.3(h)(5)(ii). Hormones such as hGH require the submission and evaluation of a New Drug Application (NDA) that contains all of the clinical trial and manufacturing data.
5. CLINICAL STUDIES WITH RECOMBINANT-DNA-DERIVED METHIONYL HUMAN GROWTH HORMONE IN GROWTH HORMONE DEFICIENT CHILDREN