Drugs

PhRMA, BIO Commend FDA Digital Health Efforts

Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) say they commend FDA for publishing a framework to guide the use of digital health technology (DHT)-derived data in regulatory decision-making for drug and biological products. The associations’ joint letter recommends that the agency consider updating the DHT framework in an iterative process to incorporate the feedback from comments received and lessons learned as FDA’s experience with DHT increases.

“Such updates would improve the framework and maximize its understandability and utility for stakeholders with the common goal of advancing the use of DHTs to improve drug development and benefit patients,” the letter says.

PhRMA and BIO also say there remains a need for more details and additional examples and use cases where DHTs have been or could be used in drug development. “It would also be helpful to better understand the agency’s approach and key considerations for the agency in evaluating DHTs proposed to measure key (primary or secondary) endpoints in clinical trials,” they add.

The FDA framework defines DHTs as “systems that use computing platforms, connectivity, software, or sensors for health care and related uses. They include technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (devices, drugs, and biologics). DHTs may also be used to develop or study medical products.”

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