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The Swiss Agency for Therapeutic Products (Swissmedic) announced that it will allow orphaned manufacturers whose Notified Bodies have ceased operation to continue marketing their devices, subject to certain conditions. Read More
The FDA has released final guidance on assessing the risks and benefits of investigational device exemption (IDE) applications for human clinical studies. Read More
The Mozambique Drug Authority is pushing the Ministry of Health and Family Welfare in India to improve the quality of drugs manufactured in India. Read More
Fifteen FDA officials, including Commissioner Robert Califf, called for broader uses of research methodologies, such as intervention and randomization, in real-world settings outside the typical venues of clinical trials. Read More