ARTICLE
13 November 2015

Inductos To Remain Suspended In EU, Pending Resolution Of Manufacturing Issues

JD
Jones Day

Contributor

Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
On October 23, 2015, the CHMP has recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures.
European Union Food, Drugs, Healthcare, Life Sciences
To print this article, all you need is to be registered or login on Mondaq.com.

On October 23, 2015, the CHMP has recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures. EMA started a review of Inductos following an inspection by Dutch and Spanish authorities, which found the production site of the absorbable sponge to be noncompliant with manufacturing requirements. Specifically, the inspectors noted that the manufacturer, located in the United States, did not have adequate measures in place to prevent particle contamination of the sponges. Hence, the CHMP concluded that Inductos should be suspended until the manufacturing issues are satisfactorily addressed.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.

ARTICLE
13 November 2015

Inductos To Remain Suspended In EU, Pending Resolution Of Manufacturing Issues

European Union Food, Drugs, Healthcare, Life Sciences

Contributor

Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
See More Popular Content From

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More