Biologics

Use Risk-Based AI/ML Regulation: AstraZeneca

Responding to an FDA request for comments on total lifecycle considerations for generative artificial intelligence-enabled medical devices, AstraZeneca says it is important that the agency use a risk-based approach to the regulation of artificial intelligence/machine learning (AI/ML). “Risk-based frameworks are an important regulatory tool used to facilitate innovation by appropriately reserving the highest level of evidence and performance requirements for products that present the significant potential risk while leveraging regulatory flexibility for lower risk products to allow advancements in technology,” the company says.

AZ also says it applauds FDA for recent efforts to increase internal expertise and resources in the area of AI/ML, and encourages it to ensure that internal expertise and development of agency thinking and policy extends beyond CDRH since CDER and CBER are increasingly responsible for the regulation of AI/ML technologies in the areas of drug endpoints, digital health technologies for remote data acquisition, combination products with medical device software constituent parts, and promotional materials.

The firm’s other two comments deal with leveraging a range of communication strategies and engaging in external collaboration.

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