PT  - JOURNAL ARTICLE
AU  - Miller, Henry I.
TI  - Recombinant DNA as a Paradigm of a New Technology: Its Impact on Regulation by the Food and Drug Administration
DP  - 1982 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 248--250
VI  - 36
IP  - 6
4099  - http://journal.pda.org/content/36/6/248.short
4100  - http://journal.pda.org/content/36/6/248.full
SO  - PDA J Pharm Sci Technol1982 Nov 01; 36
AB  - Novel technologies continually give rise to products under the regulatory purview of the Food and Drug Administration (FDA). The degree of impact on the FDA’s regulatory deliberations has several determinants. These are delineated, and recombinant DNA is employed as a paradigm of a new technology. Specific areas discussed are: the products regulated by FDA expected to be produced by recombinant DNA technology: intra-Agency jurisdiction for the various products; scientific and regulatory issues surrounding the products; and sources of the intra-Agency expertise in this area.