Frequently we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). For that reason you can now find explanations to the three most important documents in this news.
Globalisation of Manufacturing and Distributing Medicinal Products Causing Troubles according to the FDA
On the FDA website, you can find the slides of a presentation made by Robert Sklamberg, Director of CDER's Office of Compliance in May 2013. The topic deals with the challenges presented by globalisation of manufacturing and distributing. Read more here.
The ACAA between the EU and Israel entered into force on 19 January 2013. It is a framework agreement that recognizes Israeli industrial standards as equivalent to European standards and is similar to a Mutual Recognition Agreement (MRAs). Read more.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has published a Contingency Plan for exceptional waivers intended to apply where it is necessary to ensure the availability of medicinal products. Read more.
Half-year Report 2013: FDA Medical Devices Warning Letter Statistics - 2 New Deficiency Group in the Top 5
On behalf of the Eurpean Compliance Academy the team of Concept Heidelberg regularly analyses the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for the first half of fiscal year 2013 (from 1st October 2012 to 31 March 2013). The number of Warning Letters (107) issued by the Center for Devices and Radiological Health (CDRH) and the respective "District Offices" in the first half of fiscal year 2013 is considerably higher. Read more here.