3 
On November 24-25, NIH sponsored a meeting of Chairpersons of Institutional 
Biosafety Committees. A number of suggestions from that meeting will be considered 
by the RAC at its next meeting, January 8-9, 1981. 
Report from FDA 
Dr. Miller reported on a number of steps which FDA is considering relative 
to its review and approval for marketing of products of recombinant DNA 
technology. Since there is different statutory authority for different product 
classes (i.e. , drugs, foods, medical devices, biologies, veterinary medicines), 
it is likely that regulation will be on a product-by-product basis through the 
appropriate FDA Bureau. Substances produced by recombinant DNA technology will 
generally be treated as analogous products produced by conventional technology, 
with the qualification that quality assurance techniques may have to be tailored 
to assure continuous control of purity and identity of products. In addition, at 
least for the Bureau of Drugs and the Bureau of Biologies, for the present, a 
new Notice of Claimed Investigational Exemption for a New Drug (IND) and a new 
New Drug Application (NDA) will be required for a product made by recombinant 
DNA technology, even if identity is demonstrated with the natural substance (or 
with a previously approved drug, purified in a conventional way). 
Dr. Omenn asked why a new IND and NDA would be required. Dr. Miller pointed 
out that the statutory definition of a "new drug" (21 U. S. Code 321 ( p) ) is "any 
drug . . . the composition of which is such that such drug is not generally 
recognized, among experts qualified by scientific training and experience ... as 
safe and effective . . . ." Until drugs made by recombinant DNA techniques become 
"recognized [by] . . . experts ... as safe and effective," they will be treated 
[ 527 ] 
