RT Journal Article
SR Electronic
T1 Recombinant DNA as a Paradigm of a New Technology: Its Impact on Regulation by the Food and Drug Administration
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 248
OP 250
VO 36
IS 6
A1 Miller, Henry I.
YR 1982
UL http://journal.pda.org/content/36/6/248.abstract
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.