Attachment IV - Page 25 
-3- DRAFT 
NOVEMBER 7, 1983 
I • Introduction 
This document provides suggestions for controlling safety, purity, and 
potency of new drugs and biologies produced by recombinant DNA technology. The 
suggestions expressed herein are expected to change with time as new knowledge Is 
acquired, and should not be regarded as being either fixed or all-inclusive. 
Accordingly, the points discussed below should be Interpreted as being what 
manufacturers of such products are generally expected to consider during drug 
development, In applications for investigational new drug (IND) exemptions, in new 
drug applications (NDA) , and In license applications. The general regulations 
applicable to other biologies (general safety, sterility, potency, etc.) are also 
applicable to recombinant DNA biological products. Specific concerns relevant to 
particular products should be discussed with the appropriate Office on a 
case-by-case basis. 
Although considered voluntary for industry, these points represent an 
informed consensus relating' to the general safe use of products developed using 
recombinant DNA technology. 
New license applications or new drug applications are required for products 
made wl&h recombinant DNA technology, even if the product is considered to be 
identical in molecular or chemical structure to a naturally occurring substance or 
previously approved product produced in a conventional way. 
II . General Considerations 
The production of new drugs and biologies by recombinant DNA technology 
should generally follow the NIH Guidelines for Research Involving Recombinant DNA 
Molecules or other appropriate guidelines. 
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