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o Bureau of Veterinary Medicine: bovine growth hormone 
and interferon. 
o Bureau of Foo ds: certain enzymes and food additives 
used in food processing. 
o Bureau of Medical Devices and Radiological Health: 
monoclonal antibodies, in vitro diagnostic tests (e.g., 
testing components such as glucose oxidase) and 
specific tests for thalassemia. 
Recently, the FDA has shifted from individual bureau 
policy development to the development of a coordinated regulation 
policy. The F-DA has established an rDNA coordinating committee 
to decide on such procedures as how data requirements will be 
streamlined for biotechnology products whose active ingredients 
are -identical to ones- already approved and on the market. 
FDA policy, proposed by the coordinating committee, was 
approved and issued in response to applications seeking approval 
of rDNA derived substances. All pharmaceutical products 
manufactured using rDNA technology will require new drug 
applications regardless of whether or not the products are 
identical or similar to naturally occurring substances or to 
previously approved products manufactured in a conventional way. 
The amount of data that must be contained in the required 
applications will depend on a variety of factors, including the 
proposed use of the product, how long the product is to be 
administered, previous clinical experience and the applicant's 
previous experience with products created by use of this new 
technology. 
[614] 
