North America
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the following three categories: Class I, Class II, and...
North America
In recent years, the opioid epidemic has played a dominant role in the United States as opioids continue to be exploited. The National Institute on Drug Abuse states that more than 115 people die from opioid abuse every day. In May 2018, the specialty company US...
Consultant Post
Dealing with FDA deficiency letters doesn’t have to be hard, read on to find out how best to address your deficiencies.
North America
Ever wondered how to find the best predicate for your device, read on to find out more.
North America
The impending bill to repeal and replace the Affordable Care Act was unveiled earlier this month. As part of the bill, the controversial medical device excise tax imposed to help pay for the Affordable Care Act would also be scuttled. The medical device tax was first...
North America
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) proposed the withdrawal of two generic versions of Johnson & Johnson’s Concerta® marketed by Kremers Urban Pharmaceuticals, a subsidiary of the Lannett Company...
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