Susan Kelly

1 week ago | biopharmadive.com | Susan Kelly

The Food and Drug Administration’s attempt to increase regulatory scrutiny over laboratory developed tests appears to be dead, much to the relief of clinical labs. The FDA is unlikely to appeal the March 31 federal court order that set aside a final rule asserting the agency’s jurisdiction over LDTs, attorneys who handle regulatory matters said in interviews.

3 weeks ago | healthcaredive.com | Susan Kelly |Susanna Vogel

By Susan Kelly,Susanna Vogel An article fromLobby groups like the American Hospital Association and AdvaMed have so far failed to get medical devices and critical supplies carved out from the Trump administration's tariffs.

1 month ago | solicitorsjournal.com | Susan Kelly

At a time when reactionary views seem to be in the ascendant, at least on the other side of the Atlantic, it is tempting to view the Court of Appeal’s decision in Higgs v Farmor’s School on 12 February 2025 as another feather in the cap of the ‘anti-woke’ movement.

2 months ago | biopharmadive.com | Susan Kelly

President Donald Trump’s tariff plans — both real and threatened — are roiling the medical device industry due to a complex supply chain dependent on offshore manufacturing. The evolving policy caused whiplash when Trump ordered broad 25% tariffs on Canada and Mexico, before agreeing to postpone them for one month shortly after. Meanwhile, a new 10% tariff on imports from China has taken effect. Trump also threatened tariffs on the European Union.

2 months ago | biopharmadive.com | Susan Kelly

China’s Ministry of Commerce on Tuesday added Illumina, a maker of DNA sequencing systems, to its unreliable entity list as trade tensions with the U.S. flared. China also placed fashion group PVH on the list. The actions appeared to be a countermeasure to President Donald Trump’s new 10% tariff on Chinese imports, analysts said. China’s response included retaliatory tariffs on imported U.S. energy products, vehicles and farm equipment, and an antitrust investigation into Google.