Biologicals and vaccines: regulatory perspectives

The new biotechnology has opened the door to a very broad array of new pharmaceutical products which lend themselves to high degrees of purity and potency. From a regulatory point of view, the two basic questions of safety and efficacy are central to their approval for marketing. The kinds of safety tests which should be done on these new products will be discussed, as will the novel safety issues related to the use of abnormal mammalian cells as substrates for the production of some new drugs and biologicals. In addition, the relative need for efficacy studies will be discussed in the context of a genetically engineered product when the "natural" product has already been shown to be effective and is commercially available.