Senators this week introduced a bipartisian bill that would update the Food and Drug Administration’s process for inspecting medical devices. The bill — sponsored by Sens. Michael Bennet, D-Colo., and ...
The FDA has arrived at your premises. What is your reaction? Are you ready? If you’re lucky, the FDA might have announced that they’re coming, but otherwise, they may turn up at any time. This means ...
An independent watchdog group says the government has quietly scaled back enforcement of federal quality regulations at labs that develop medical devices. Subscribe to read this story ad-free Get ...
Kim Trautman, an industry expert, shares some practical tips and tools for companies to navigate FDA’s new inspection process ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
On Friday’s MedHeads, reporters Neil Versel and Meghana Keshavan joined Digital Health Editor Stephanie Baum to discuss issues addressed at the RESI conference, a bubble brewing in the biotech sector ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials since 2007, according to a new report. “As medical ...
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