ABSTRACT

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 2|14 pages

Regulatory Strategy

chapter 3|37 pages

What Is an IND?

chapter 5|13 pages

Meeting with the FDA

chapter 6|22 pages

Biologics

chapter 7|42 pages

FDA Medical Device Regulation

chapter 9|23 pages

Good Clinical Practices