ABSTRACT
Human growth hormone is now available in large quantities manufactured by recombinant DNA technology. This has enabled the utilisation of this product in areas outside growth hormone deficiency to begin. However, a review of the literature indicates that satisfactory evidence for efficacy and safety are not available for any new indications.
There needs to be a consensus developed as to what data is needed in order to allow registration of these new indications for marketing approvals.
The new European Community Directive on biotechnology products is encouraging the development of such areas, but there are some potential obstacles to industry being encouraged to invest in these areas.
