Skip to main content

FDA Takes Aim at Drug Inserts

The agency is revising the format of package inserts for the first time in more than 25 years.
  • Author:
  • Publish date:

The Food and Drug Administration is planning a major revision to the format of prescription drug package inserts in a move aimed at giving doctors and patients information they can more easily understand.

The agency said in a statement on its Web site Wednesday that the plan is intended to manage the risks of medication use and reduce medical errors. The new package inserts will provide the most up-to-date information in an easy-to-read format, the FDA said.

Going forward, inserts will have to meet specific graphical requirements, and critical information will be reorganized so that doctors can find what they need quickly.

The new inserts will contain, among other things, a highlights section, a table of contents and information about how suspected side effects can be reported. Package inserts are being revised for the first time in more than 25 years, the FDA said.

TheStreet Recommends

The new rules will go into effect on June 30.