FDA Introduces New Strategy to Ensure Safety of Imported Products

Did You Know?

If your company or organization is subject to FDA regulations, it's important to know that this month marks the introduction of some new and important changes at the FDA.

According to a recent FDA news release, Margaret Hamburg, Commissioner of Food and Drugs, described the need for change as follows:

"Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete. There has been a perfect storm - more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented."1

To address these challenges, the FDA will address an increasing number of imports with the following measures:

  1. More partnerships with private and public third-party entities.
  2. Development of regulatory coalitions across world markets.
  3. Increased information gathering and increased focus on risk analytics.
  4. Allocate appropriate resources to risk management.

Learn More

To learn more about the FDA's new global strategy, please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259848.htm