Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed b

chapter 1|18 pages

Overview of Drug Development and the FDA

ByDouglas J. Pisano

chapter 2|14 pages

Regulatory Strategy

ByJacqueline A. Dombroski

chapter 3|37 pages

What Is an IND?

ByRobert G. Pietrusko, Thomas Class

chapter 5|13 pages

Meeting with the FDA

ByAlberto Grignolo

chapter 6|22 pages


ByJames G. Kenimer, John J. Jessop

chapter 7|42 pages

FDA Medical Device Regulation

ByBarry Sall

chapter 8|11 pages

The Development of Orphan Drugs

ByMarlene E. Haffner

chapter 9|23 pages

Good Clinical Practices

ByRobert Buckley

chapter 12|17 pages

The Practice of Regulatory Affairs

ByDavid S. Mantus