Late last year, the U.S. Food and Drug Administration released the final guidance on Medical Device Reporting (MDR), a critical quality component of a company’s complaint management system.
3D printing technology not only offers great potential to create drugs that are easier to consume and more effective, but also potential efficiencies throughout the research, development, and manufacturing process—even the supply chain.
Improving patient safety is at the heart of the medical device industry, but many manufacturers may not realize that this starts with data integrity in the manufacturing process.
Pharmaceutical Commerce talks about the benefits automated validation for regulated industries.
Earlier this fall, several major brands voluntarily recalled products due to potential listeria concerns in cookie dough ingredients.
In November 2016, FDA released its final guidance on medical device reporting (MDR). MDR has been an intrinsic part of the medical device regulatory process for many years. There’s no specific change or new information in this document, but it does answer some fundamental questions about when and how to do things. It is organized as an FAQ-style reference, to be used in conjunction with online Medical Device Reporting requirements and guidelines.
Beginning in early 2017, life sciences organizations that intend to manufacture and/or market medicinal products within the European Union will be required to comply with the Identification of Medicinal Products (IDMP) regulations, a global framework for identifying medicinal products, set forth by the European Medicines Agency (EMA).
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