Regulation of Pharmaceuticals: Balancing the Benefits and Risks

by John M. Vernon and Henry G. Grabowski

Although the US pharmaceutical industry has had an outstanding record in innovation since the 1930s, new drugs have been subject to increasingly stringent regulatory controls in the past 20 years. The 1962 Kefauver drug amendments required the innovating firm to prove the safety and efficacy of a new drug to the Food and Drug Administration (FDA) and instituted strong regulatory controls over the clinical development process. As a consequence,...

• Format: Paperback
• Language: English
• ISBN: 0844735175
• ISBN13: 9780844735177
• Release Date: January 1983
• Publisher: AEI Press
• Length: 1 Pages
• Weight: 0.27 lbs.
• Dimensions: 0.2" x 6.0" x 9.0"