USFDA news and notes
New draft Guidance Documents:
The CDRH appeal process: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm282958.htm
The 510k process and substantial equivalence: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm284651.htm
Keep track of what`s new at the FDA on these new documents, several other new Guidance Documents and other regulatory news at:
http://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm
European Union/CE Marking news and notes:
On February 23, 2012 the United Kingdom’s competent authority, the MHRA is hosting a symposium on Assessing the Safety of Biological Medicines, Biosimilars and Advanced Therapies throughout the Product Life Cycle. For more information see http://www.mhra.gov.uk/ConferencesLearningCentre/Conferences/CON134949
Effective January 2012 there is a new technical evaluation requirement for all EU member states acting as Reference Member State (RMS) for new MA applications to perform a technical validation of eCTD submissions. This RMS validation will also be accepted by all Concerned Member States (CMS) – it is not envisaged that CMS carry out their own independent eCTD validation. To comply with this requirement, from 3 January, the MHRA will be technically validating all new MAA eCTD submissions for both National procedures and where the UK is RMS. For more information... http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON137941
On 1 March 2012 the MHRA will be holding their 5th annual seminar on medications for children and other special populations. For more information... http://www.mhra.gov.uk/ConferencesLearningCentre/index.htm
Australian TGA news and notes:
The Australian TGA posts presentations made by its staff. Recent topics include plant inspections and risk management. http://www.tga.gov.au/newsroom/events-presentations-manuf.htm
ISO and IEC Standards new and notes:
Having the most recent edition of a reference standard is critical to smooth product testing and regulatory approvals. Care to monitor the international standards development process... check out these features: http://www.iso.org/iso/search/pred_searches.htm for the latest ISO Standards and http://www.iec.ch/dyn/www/f?p=103:109:0 for the latest IEC Standards.