 |
|
|
|
The signing of the Kefauver-Harris amendments was the top story in this FDA newsletter, published in November 1962.
|
|
|
October 10, 1962:
The Kefauver-Harris Drug Amendments are passed, prompted in part by public concern over birth defects caused by the drug thalidomide. Among the new requirements: proof of drug effectiveness as well as safety, controls over clinical trials, and better quality assurance practices in drug manufacturing.
|
|
|
|
Since 1962, the FDA has continued to refine its drug review practices and its oversight of clinical research— the human studies done to prove the safety and effectiveness of drug treatments. In June 2006, the agency announced a Human Subject Protection and Bioresearch Monitoring Initiative that will improve the protection of human subjects and the integrity of data in clinical trials for medical |
|
devices, foods, human drugs, biological drug products and veterinary drugs. "As clinical trials continue to evolve, in particular becoming increasingly large, decentralized and global, the FDA's approach to bioresearch monitoring and human subject protection must also evolve and modernize," FDA Deputy Commissioner Janet Woodcock, M.D., said about the initiative.
|
|
