14 
The National Center for Drugs and Biologies was formed 
in May 198 2 by merging the two previously separate bureaus. The 
objective of FDA was to facilitate the creation of an improved 
science base for the drug review process and increase its 
ability to assure the safety and efficacy of drugs and 
biological products. As products related to biotechnology are 
reviewed* by the National Center for Drugs and Biologies, a 
positive trend is emerging: industry and federal regulators are 
interacting more frequently and are sharing scientific expertise 
to address, more rapidly, questions related to product safety and 
efficacy. 
Based on the demonstrated identity of molecular 
structure of natural and rDNA made products, it is likely that 
pharmaceuticals will qualify for the FDA’s ’’fast track” New Drug 
Application review, although each product will be reviewed ’’case 
by case”. The fast track at FDA involves more intense and 
frequent scrutiny prior to the review process for drugs that are 
"new” (not merely extant products manufactured by new 
technology), with the aim of expediting the approval and 
marketing of drugs that are not presently available and provide 
pharmaceuticals for new indications. 
The regulation of veterinary products derived from 
biotechnology under the Bureau of Veterinary Medicine is 
analogous to regulations of products for human use. However, if 
the animals are food-producing animals, the drugs must also be 
shown to be safe for human consumption and must not leave unsafe 
residues in the animal-derived food for human consumption. 
[615] 
