ABSTRACT
The preceding chapters have discussed a variety of scienti¢c, technical, and regulatory considerations related to the development and approval of generic drug products. To compliment that discussion, this chapter is written from the perspective of a lawyer specializing in the drug regulatory process. This chapter discusses a variety of legal and legislative considerations, as well as some miscellaneous regulatory considerations. There are, of course, no clear lines dividing the ‘‘scienti¢c,’’ ‘‘regulatory,’’ and ‘‘legal’’ arenas in the context of generic drug development and approval. While some of the disputes discussed in this chapter have a ‘‘scienti¢c’’ underpinning, the matters have often presented themselves in the litigation context.
