FDA Roundup: March 15, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA published its new paper, “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines specific focus areas regarding the development and use of AI across the medical product lifecycle. The paper helps further align and streamline the agency’s work in AI. Read more about the agency’s AI initiatives on our website.
• Today, the FDA published the “Catching Up with Califf: Harnessing the Potential of Artificial Intelligence,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. The Commissioner discusses how the agency has been working for years to anticipate and prepare for the challenges of Artificial Intelligence (AI), and also to harness its potential. Since 1995, the FDA has received over 300 submissions for drugs and biological products with AI components, and more than 700 submissions for AI-enabled devices. The agency is also exploring the use of AI technologies to facilitate internal operations and regulatory processes. The blog links to the new paper: “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.”
• On Thursday, the FDA revoked the standards of identity and quality for frozen cherry pie. The standards are no longer necessary to ensure that these products meet consumer expectations, and revoking the standards will provide greater flexibility and the opportunity for product innovation. The action supports the FDA’s goal to modernize standards of identity.
• On Thursday, the FDA issued a safety alert, advising restaurants and retailers of a recall conducted by the Connecticut Department of Agriculture, Bureau of Aquaculture of certain oysters from Westport, Connecticut potentially contaminated with norovirus.
• On Thursday, the FDA announced the Medical Device Sterilization Town Hall: The Value and Use of Recognized Consensus Standards in Premarket Submissions that will be held on Thursday March 21, 2024, 12-1 p.m. ET.
• On Thursday, the FDA issued an updated draft guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The Medical Device User Fee Amendments of 2022 (MDUFA V) commitment letter includes refined performance goals related to the FDA feedback for Pre-Submissions or “Pre-Subs,” which are part of the Q-Submission Program. Additionally, as part of MDUFA V, the FDA committed to issuing a revised draft guidance by March 31, 2024, including information on when informal communication is appropriate instead of a Pre-Sub. This updated draft guidance meets this commitment.
• On Thursday, FDA approved Breyanzi (lisocabtagene maraleucel) a cell-based gene therapy to treat adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, was previously approved for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
  • Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
  • Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
  • Relapsed or refractory disease after two or more lines of systemic therapy.

Patients and clinical trial participants receiving treatment with CAR T cell immunotherapies should be monitored life-long for new malignancies. If a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the Chimeric Antigen Receptor (CAR) transgene.
This indication was approved through the Accelerated Approval pathway.

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