Drugs

FDA Guide on IVDs Used in Precision Medicine Development

FDA has released a draft guidance on “Investigational IVD Used in Clinical Investigations of Therapeutic Products” to help researchers involved in precision medicine development determine if an in vitro diagnostic (IVD) device used in a drug study will require a separate agency review from the drug being studied. The agency says the guidance:

describes when the IDE regulation may apply to certain clinical investigations;
describes certain regulatory requirements sponsors should be aware of as they develop and conduct investigations;
provides recommendations for determining the risk of investigational IVDs;
provides recommendations for IRBs in reviewing such investigations; and
provides recommendations for content to provide in an IDE application.

In a related post, FDA commissioner Scott Gottlieb says that the guidance, when finalized, will “clarify the appropriate regulatory pathway for investigational IVDs used in clinical trials for therapeutic products, which is significant so that trial results for a novel targeted therapy are not undermined just because the diagnostic test to determine a specific biomarker did not meet appropriate regulatory criteria... Building on the IVD draft guidance issued today, we are also considering ways to streamline the review of oncology therapeutic products and the IVDs used with these products, and plan to issue draft guidance on this in the near future. The goal is to reduce the burden on sponsors for the development of certain cancer drugs, and on FDA staff as well.”

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