 |
|
|
|
|
I. Introduction |
|
|
|
| |
|
|
|
|
|
II. Product Liability Issues in Drug Development |
|
|
|
| |
|
|
|
|
|
A. Basis of Liability in Drug Development |
|
|
|
| |
|
|
|
|
|
B. Factors Shifting Liability to the Manufacturer |
|
|
|
| |
|
|
|
|
|
C. Effects on the New Drug Development Process |
|
|
|
| |
|
|
|
|
|
D. Product Liability Reform |
|
|
|
| |
|
|
|
|
|
III. The Impact of Cost Containment on Drug Development |
|
|
|
| |
|
|
|
|
|
A. The Political and Regulatory Environment |
|
|
|
| |
|
|
|
|
|
B. Market Forces Behind Health Economic Issues |
|
|
|
| |
|
|
|
|
|
C. Effects on Innovation |
|
|
|
| |
|
|
|
|
|
IV. Conclusion |
|
|
|
| |
|
|
|
|
|
References |
|
|
|
| |