FDA Policy/General

Pay Attention to FDA AI Reviews: Attorneys

Three Morgan Lewis attorneys say FDA’s decision to use artificial intelligence (AI) to help agency reviewers should spur regulated companies to prepare to evaluate and respond to reviews that reflect AI input. Writing in an online post, the attorneys say that if the AI tool flags a concern or discrepancy, sponsors should be prepared to explain or contest it to the extent appropriate. In practice, they write, this means providing clear, well-documented data to allow any AI conclusions to be traced and validated as well as clear explanations for why a finding may be without merit.

“Companies should also begin noting whether they experience a decrease in accuracy or quality in FDA communications,” they say. “This information can help identify areas where the performance of the AI is lacking and be an important data point in response to FDA inquiries.”

To support an efficient review, especially given the agency’s current staffing challenges, companies should ensure submission files are well-structured and complete so they can be interpreted by the AI application, the attorneys say. Companies should pay attention to data formatting and labeling, as inconsistencies or missing metadata could be more easily spotted by AI or compromise the review.

“FDA emphasizes that AI will augment, not replace, human experts; reviewers remain responsible for directing the AI assistant and verifying its outputs,” the post concludes. “Going forward, however, sponsors should account for FDA’s use of AI during product reviews. By anticipating these changes, manufacturers can adapt their submission strategies.”

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

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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