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.
New: ICH Guideline for ICH Q8, Q9 and Q10 implementation
There is still a lot of uncertainty about how the three guidelines should be used in combination. A new Points to Consider document is intended to provide clarification. Please find more information here.
On 1 January 2011, FDA joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) . Now, Dr Margaret A. Hamburg, Commissioner of the FDA, gave an interesting talk about the membership and its benefits. Read more.