With the new "Super Office", the US Food & Drug Administration (FDA) restructured the Office of Compliance - the most important Office in the field of GMP.
Unanimously, different media - including PharmTech - have reported about the reorganisation of the Office of Compliance. The so-called "Super Office" will be extended to four further divisions. The new office called Office of Drug Security, Integrity & Recalls (ODSIR) is a response to the challenges of growing globalisation in the area of drug manufacturing and the related risks of counterfeit medicines.
The new central office shall bring together all the activities linked to the monitoring of the supply chain and counterfeit medicines. The important areas "Import of APIs and drugs" and "Recalls" will be in the hand of the new office.