Devices

HHS Should Reverse LDT Policy: House Committee

The House Energy and Commerce Committee leadership has written to HHS secretary Xavier Becerra urging that he reverse the Trump administration HHS decision to remove FDA authority to require premarket review of Covid-19 laboratory-developed tests (LDTs). The 5/11 letter says that at the time former HHS secretary Alex Azar made the decision, the committee leaders said it “raised questions about the reliability of tests on the market and threatened to alter our understanding of Covid-19 outbreaks and the progression of the pandemic.”

While FDA has typically exercised enforcement discretion for LDTs, the letter says, allowing such tests to come to market without prior review, FDA has maintained that it has jurisdiction over the tests.

The representatives review the history of the Trump administration’s actions and say the “long winding path of regulatory uncertainty has been misguided from the start. The former FDA commissioner and career scientists at FDA reportedly opposed the move, telling HHS officials that the decision could lead to inaccurate tests flooding the market…. We ask that you take steps to ensure the quality of these tests by reversing the Trump administration’s misguided policy on LDTs and restoring FDA’s premarket review authority.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome