In the postmarket setting, the regulation of medicines requires an assessment of the balance between their benefits and risks and, as new information becomes available, may require regulatory actions that range from changes in the product label to withdrawal of a drug from the market. A series of unforeseen consequences of drug administration to vulnerable patients has shaped the modern history of the regulation of medications. In the 1960s, for instance, thalidomide given to pregnant women resulted in birth defects or death in several thousand of their offspring. The framework for modern drug regulation largely emerged from the development of various measures to prevent similar drug-safety disasters.
Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more
Subscribe for full-text access to content from 1998 forward and a host of useful features
Activate your current subscription (AMA members and current subscribers)
Purchase Online Access to this article for 24 hours
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 4
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
and access these and other features:
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.