Drugs

FDA Digital Health Technologies Framework

FDA has published a framework that it says it will use to implement a multifaceted digital health technologies (DHT) program for drugs. The document notes that the PDUFA 7 commitment letter stating the agreements between the agency and industry for reauthorization of PDUFA, included goals relating to using DHTs to support drug development and review.

The framework defines DHTs as “systems that use computing platforms, connectivity, software, and/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.”

The DHT program will include workshops and demonstration projects; engagements with stakeholders; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents, the framework says.

The agency says that DHTs and DHT-derived data can be important tools in supporting timely access to safe, effective, and innovative new medicines. DHTs can be used to increase decentralization of trial-related activities, it says, improve patient access to trials, increase trial diversity, and promote retention by facilitating remote trial-related measurements. DHTs also can facilitate the direct collection of information from participants who are unable to report their experiences. And they may allow for developing novel endpoints that can provide a broader picture of how participants feel or function in their daily lives.

“Despite the potential advantages of DHTs,” FDA concludes, “many challenges arise when incorporating DHTs and DHT-derived data into regulatory decision-making. This framework outlines a multifaceted approach to collaboratively address these challenges with our stakeholders. Through these joint efforts, we intend to advance the development of drugs and promote the public health.”

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

Read more

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