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.
South America
Brazil is the largest medical device market in Latin America, and has an established but complex regulatory system. Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). ANVISA in its effort to streamline medical device...
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...
North America
It has been a tumultuous time for many CEOs and executives in America, from Martin Shkreli to John Stumpf and Heather Bresch. Their companies have been involved in high-profile tussles with Congress on issues including drug pricing, R&D costs, aggressive marketing...
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