BASECOL MIX identifica problemas em lotes de vitaminas
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Health Canada is initiating the transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), in order to improve the availability, access to, and the quality of information available on medical devices in Canada. Continuous and significant technological advancement in the field of medical devices makes it necessary for Health Canada to implement a nomenclature designed to keep pace with medical devices innovations.
Health Canada’s decision to use the GMDN is in line with the recommendation of the International Medical Device Regulators Forum (IMDRF) and supports the Federal Government’s Open Government initiative by improving the quality of medical devices data available to the public and leading to greater transparency.
The GMDN is an identification tool used worldwide by several medical device regulators. It is a list of generic names used to identify medical device products, allowing for efficient and timely information exchange between jurisdictions and effective monitoring by regulators. The GMDN database currently includes over 23 000 active terms covering all major technologies and intended uses, and is in constant evolution.
By adopting the GMDN, Health Canada will be in a better position to fulfill its mission to help Canadians maintain and improve their health, since better quality information will be available to Canadian health authorities, health care providers, manufacturers, and Canadians. This initiative will also lead to improved communication within the health-sector, will help Health Canada better understand and monitor medical device safety, and allow timely provision of more accurate information in response to internal and external stakeholders’ requests for information.
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For more information go to https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-global-medical-device-nomenclature.html
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FDA issued a guidance for industry entitled ‘‘Bioanalytical Method Validation.’’ This guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data.
To access the guidance go to https://www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf
The Seventy-first World Health Assembly: Interview with Dr. James Fitzgerald, Director of Health Systems and Services PAHO/WHO about Universal health coverage: what it means and how we can achieve it: http://www.who.int/world-health-assembly/seventy-first/social-good
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