Deals Shaping The Medical Industry, May 2020
Derived from Biomedtracker, the Deal-Making column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing.
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Warning Letters And Close-Outs – April 2024
The US Food and Drug Administration released eight warning letters and one close-out last month. Big names caught in the net included Beckman Coulter, Royal Philips and Cardinal Health.
To Be (a device) Or Not To Be. That’s The Legal Question
Now that the US FDA has published its final rule regulating lab developed tests, litigation challenging the rule and the FDA’s authority to enact it is sure to follow. And the central argument will likely focus on whether the tests are defined as medical devices, which the agency regulates without question.
Califf Says US FDA Ready If Human Avian Flu Infections Jump
The FDA commissioner said an H5N1 vaccine can be developed from the same mRNA platform used to create the COVID-19 vaccines, but funds are needed to ensure production can begin quickly if a human outbreak occurs.
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