CAMBREX SUBSIDIARY APPLIES FOR HUMANITARIAN DEVICE EXEMPTION
On July 17 Cambrex Bio Science Walkersville, Md., a subsidiary of Cambrex and Ortec International, announced that it submitted a humanitarian device exemption (HDE) application to the FDA requesting approval to market cryopreserved OrCel for the treatment of a congenital skin disorder.
The FDA has approximately 75 days to respond to the HDE application. An HDE is an application that is similar to a premarket approval (PMA) application, but exempt from the effectiveness requirements of a PMA.
According to the FDA, and HDE is used for a device that is "intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States."
Cambrex Bio Science Walkersville and Ortec International previously signed a multi-year agreement for Cambrex to manufacture, market and distribute OrCel in the United States. Upon approval by the FDA, Cambrex Bio Science Walkersville will provide the product to patients.
For more, go to: ir.cambrex.com/phoenix.zhtml?c=80683&p=irol-newsArticle&ID=882823 (http://ir.cambrex.com/phoenix.zhtml?c=80683&p=irol-newsArticle&ID=882823).