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Last updated 12 months ago
12 months ago
Welcome to another installment of This Week at FDA, your weekly source...
12 months ago
The US Food and Drug Administration (FDA) is requesting stakeholder input on...
12 months ago
Oncology drugs approved in Japan over the last 20 years are increasingly...
12 months ago
COLUMBUS, OH – Device recalls often take more than a year to...
12 months ago
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
12 months ago
For companies that cannot use either of the preferred means of demonstrating...
12 months ago
The draft guidance describes using externally controlled clinical trials in evidence for...
12 months ago
“We need to establish that risk management doesn’t end when you initially...
12 months ago
In a newly released draft guidance, the US Food and Drug Administration...
12 months ago
COLUMBUS, OH – While sky-high demand was one of the key drivers...
12 months ago
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.