Practical, legal, and ethical issues in expanded access to investigational drugs.

@article{Darrow2015PracticalLA,
  title={Practical, legal, and ethical issues in expanded access to investigational drugs.},
  author={Jonathan J Darrow and Ameet Sarpatwari and Jerry Avorn and Aaron S Kesselheim},
  journal={The New England journal of medicine},
  year={2015},
  volume={372 3},
  pages={279-86}
}
The Food and Drug Administration (FDA) reviews clinical-trial data for new drugs and determines whether the benefits of these drugs outweigh the risks.1 This requirement, legislated in 1962,2 raised the bar to approval and reduced the likelihood that new drugs would be ineffective or cause major health problems. Developing such data about investigational… CONTINUE READING