The ECA provides the FDA Warning Letters Analysis on a regular basis. This news describes the development of the 2002 to 2011 Warning Letters Top Five list with regard to medical devices. The number of Warning Letters issued by the Center for Devices and Radiological Health (CDRH) is…. read more.
First ECA/EQPA Conference in the U.S. a great Success
From 7-9 June 2011, the first joint conference of the European Compliance Academy and European QP Association was held in Bethesda, Maryland on European GMPs and the duties and responsibilities of the Qualified Persons according to the European regulations. Find out more.
FDA publishes List of Guidance Documents for Medical Devices
In early October the FDA published a list in the Federal Register presenting documents regarding the regulation of medical devices which are to be considered for development in the fiscal year 2012 (October 2011- September 2012). Read more here.
FDA strives for more Transparency regarding GMP Compliance and Enforcement Data
The US Food and Drug Administration (FDA) has issued a report in which it proposes to make Compliance and Enforcement Information more accessible and user-friendly. The proposals are part of FDA's current efforts to make its operation and decision making more transparent. Read more.
EMA Reflection Paper provides Concrete Information about Risk based Quality Management
The "Reflection paper on risk based quality management in clinical trials" recently published by the EMA contains a table (Annex 1) which presents the points to consider for the risk identification, examples of how to control them and eventually mitigation and/or acceptance solutions. This gives interesting insights into EMA's specific positions about risk control. Read more here.
After the first five successful years of its existence, the European Qualified Person Association (EQPA) decided to develop a new structure and to integrate more colleagues into its activities. Read more.
The organisation and the regulations of the US Food & Drug Administration (FDA) are frequently considered hard to comprehend. With regard to medical devices the CDRH runs a quite detailed website. Read more.
FDA publishes SOP for "Notice to Industry" Letters for the Medical Devices Industry
The FDA Center for Devices and Radiological Health (CDRH) has published a SOP to describe how it will inform Medical Devices manufacturers about new or modified requirements/expectations by use of "Notices to Industry" Letters in the future. Read more.