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[IE] IMB: Drug Safety Newsletter 38th EditionTopics covered in this edition of the newsletter include: Rosiglitazone (Avandia/Avandamet) Isotretinoin (Roccutane) Warfarin Carbapenems BCG Vaccine Bevacizumab (Avastin) Panitumumab (Vectibix) Drug Safety Newsletter - 38th edition [EU] EMA: International workshop on the ethical and good clinical practice (GCP) aspects of clinical trials conducted in third countries - September 6-7 2010, London, UK, From: 06-Sep-2010, To: 07-Sep-2010The workshop will enable participants to discuss and provide feedback on the 'Draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorization applications to the EMA' which was released for public consultation on the Agency's website in May 2010. The workshop complements this consultation process. Conclusions from the workshop and copies of the presentations will be subsequently published in a short report. Please note that registration for the workshop is now closed. [IE] IMB: Medical Devices Newsletter No. 29 - August 2010Content - Editorial - Changes to the Medical Devices Legislation that Impact Custom-made Medical Device Manufacturers - New Approach and the IMB Post Market Surveillance Plan - SCENIHR's Report on the Safety of Reprocessing Single-Use Medical Devices - Regulatory Update - Changes to MEDDEV 2.4/1 on the Classification of Medical Devices - European Commission Public Consultation on the Revisi... [IE] IMB: Guide for Custom-made Medical Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994The Irish Medicines Board has revised guidance for Custom-made medical device manufacturers on compliance with European Communities (Medical Devices) Regulations, 1994. The guidance has been updated in line with amendments introduced by the coming into force of Directive 2007/47/EC and the related Irish transpositions S.I. No. 109 of 2009 and S.I. No. 110 of 2009. Further details on the changes ca... [IE] IMB: Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994The Irish Medicines Board has revised guidance for Class I manufacturers on compliance with European Communities (Medical Devices) Regulations, 1994. The guidance has been updated in line with amendments introduced by the coming into force of Directive 2007/47/EC and the related Irish transpositions S.I. No. 109 of 2009 and S.I. No. 110 of 2009. Further details on the changes can be found in the g... [DK] Danish Medicines Agency: Decisions on general reimbursement for medicinal productsThe Danish Medicines Agency has completed its review of an application for general reimbursement for Procoralan. The product is neither eligible for general or general conditional reimbursement. [DK] Danish Medicines Agency: About gold dental crowns from Oversea Labs: Experts assess there to be no health risk associated with the dental crownsOn 29 August, DR TV (Danish Broadcasting Corporation) broadcast a story on the Danish company Oversea Labs, revealing that the company’s gold dental crowns according to DR’s analysis of five teeth did not contain as much gold as they were supposed to. The Danish Medicines Agency now follows up on the case. |
These European updates are some of the recent key regulatory news items we have noted, including those from the regulatory agencies and authorities in Europe. A two-letter code is used at the beginning of each item to indicate the country or region, according to the