Drugs

FDA Digital Health Technology Guidance

Five King & Spaulding lawyers say a 12/2021 FDA draft guidance on digital health technologies (DHTs) is a “pandemic silver lining.” In an online post, the lawyers say the draft describes the agency’s thinking about how sponsors, study investigators, and others can use DHTs to gather health-related information from study participants to evaluate the safety and effectiveness of investigational medical products.

The post says the guidance has recommendations on the information that sponsors should include in an IND or IDE application for a clinical investigation in which the sponsor plans to use a DHT or in a marketing application that includes such a clinical investigation. The recommendations relate to the selection of DHTs that are suitable for use in a clinical investigation; the description of DHTs in a regulatory submission; verification and validation of DHTs for use in a clinical investigation; the definition and evaluation of clinical endpoints from data collected using DHTs; risk management considerations when using DHTs; the protection and retention of records; and additional sponsors and investigator considerations for using DHTs in a clinical investigation.

The post summarizes each of the sections.

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