Drugs

FDA Gives States Coronavirus Testing Authority

FDA has updated a policy issued last month on diagnostic testing for coronavirus to expand the number and variety of diagnostic tests available in health care settings, and reference and commercial laboratories. The updated policy allows states to take responsibility for tests developed and used by laboratories in their states, similar to what FDA granted to the New York State Department of Health last week. “States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA,” an agency release says. “Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA. Nor will these laboratories pursue an Emergency Use Authorization (EUA) with the FDA.”

Additionally, FDA is expanding its policy to commercial manufacturers distributing and labs using new commercially developed tests to allow their use prior to the agency granting an EUA, under certain circumstances. “During this public health emergency, the FDA does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s Web site,” it says. The agency gives manufacturers 15 business days to prepare an EUA submission for a test whose performance characteristics have already been validated by the manufacturer.

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