Jul 9, 2020
COVID-19
The LÆGEMIDDELSTYRELSEN, the Danish Medicines Agency, published guidance describing the extraordinary measures for clinical trials in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). COVID-related Regulatory Background The Danish Medicines...
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Mar 25, 2020
FDA
The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, issued guidance highlighting the way the clinical trials of medical products should be conducted during the COVID-19 pandemic. The scope of the document covers all...
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Nov 15, 2019
Uncategorized
The International Medical Device Regulators Forum (IMDRF) has released guidelines on clinical evaluations, clinical investigations, and clinical evidence for medical devices. These documents replaced the previous documents that regulated the same areas as issued by...
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Jul 18, 2019
North America
RBM is essential in clinical trials, where sponsors monitor clinical investigations and determine any problems or risks involved with their studies that could impact participants or the general public. The FDA wants to improve this monitoring system to make it quicker...
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Jun 7, 2017
Asia
China Food and Drug Administration (CFDA) recently proposed policies to streamline and accelerate drug and medical device approvals as part of its regulatory reform. Below are highlights of some noteworthy changes that impact new drug and device approval...
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