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.
FDA plans on publishing further GMP and CMC Guidances for Combination Products
A drug and a device, a drug and a biological, a biological and a device, or maybe even all three can create a combination product. But what regulation is applicable for those products? Which new Guidance documents will be published soon? Please read more about this development in a very detailed article provided by the IPQ - one of the most important Journals in the GMP and regulatory environment. Read on here.
The EU has revised Annex 14 of the EU GMP Guide, defining requirements for drugs derived from human blood or plasma. In this context, requirements for the respective Qualified Persons have been updated. Read more.