FDA Roundup: January 17, 2025

FDA News Release

• For Immediate Release: January 17, 2025

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

• Today, the FDA announced the release of a new prevention strategy aimed at combating the contamination of fresh and frozen berries with enteric viruses, such as Hepatitis A Virus and Norovirus. This strategy outlines a series of actions designed to enhance communication, implement consistent prevention measures globally, and fill significant research gaps in the detection and management of these enteric viruses. Key components include fostering scientific research to understand enteric viruses' behaviors in various environments and enhancing surveillance efforts that have been ongoing since FY19 to FY23. This comprehensive approach underscores the FDA's commitment to reducing foodborne illnesses linked to berry consumption through collaborative efforts with industry interest holders and global partners. For more information, the FDA encourages visiting Prevention Strategies to Enhance Food Safety or contacting FoodSafetyPreventionStrategies@fda.hhs.gov.
• Today, the FDA issued a notice in the Federal Register announcing a virtual public workshop entitled "Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development." The purpose of this workshop is to discuss the current state of the science for development and testing of certain cellular therapies and tissue-based products. In particular, the FDA is convening this public workshop with relevant stakeholders to discuss best practices on generating scientific data necessary to further facilitate the development of cellular therapies, including stem cell products.  
  The public workshop will be held virtually on February 25, 2025, from 8:30 a.m. – 5:00 p.m. Eastern Time. Registration by 8:30 a.m. on February 25, 2025, is required. Those interested can submit electronic or written comments on this public workshop utilizing the process provided in the Federal Register. Additional information about this workshop is available on FDA’s website.  

• Today, the FDA released the IT Operating Plan for Fiscal Years 2024 - 2027, which provides the agency’s strategic blueprint for technology and data in support of advancing public health. The plan incorporates ongoing collaboration with the FDA’s executive committees and advisory boards to ensure these efforts continue to align with the FDA mission and IT and data goals.

  The plan also emphasizes increased global collaboration to strengthen public health response, leveraging emerging technologies like artificial intelligence, enhancing data sharing and developing and maintaining advanced cybersecurity practices. The plan was developed with input through workshops, listening sessions and a Federal Register Notice. By modernizing IT capabilities, optimizing investments and creating a unified "OneFDA" digital ecosystem, the agency enhances its efficiency, improves stakeholder experiences and best supports innovation in public health.

• On Thursday, the FDA announced a public workshop, Optimizing Pregnancy Registries. The purpose of the workshop is to discuss challenges in designing and implementing pregnancy registries and consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy.   
  The workshop will be held March 27 – 28, 2025, on-site at the FDA’s White Oak Campus and virtually. Registration is required.
• Today, the FDA issued the Center for Devices and Radiological Health (CDRH) 2024 Annual Report. The report illustrates the many ways CDRH continues to advance safe, effective, and high-quality medical devices, and safe radiation-emitting products. CDRH took significant actions to protect and promote the public health and improve device safety, while fostering the development of medical devices that address unmet needs and provide a significant benefit to patients in the U.S.

• On Thursday, the FDA issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities. 

  “A critical focus of the FDA is preventing and mitigating potential medical device shortages. From ventilators and neonatal breathing tubes to hemodialysis catheters, the scarcity of these critical devices poses a growing threat to patient care – especially for our youngest and most vulnerable populations. While the vulnerabilities in the medical device supply chain are not new, we are growing increasingly concerned that the rise in shortages is having a significant adverse impact on neonatal and pediatric patients,” said Michelle Tarver, M.D., Ph.D., director of the Center for Devices and Radiological Health.

  The FDA is interested in hearing from health care facilities and providers that may be having difficulty obtaining medical devices, as well as from other interested parties who may be impacted by potential shortages. Please email the FDA at deviceshortages@fda.hhs.gov.

• On Thursday, the FDA announced an early alert about Fresenius Kabi USA recommending certain software versions of the Ivenix Infusion System be updated related to a potentially high-risk device issue. The company reported two anomalies associated with software versions 5.9.2 and earlier. These anomalies have the potential to cause serious patient harm or death, including patients being underdosed or over infused.
• On Thursday, the FDA approved Lumakras (sotorasib) with Vectibix (panitumumab) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The FDA also approved the therascreen KRAS RGQ PCR Kit (QIAGEN GmbH) as a companion diagnostic device to aid in identifying patients with colorectal cancer whose tumors harbor KRAS G12C mutations and who may be eligible for Lumakras with Vectibix. The most common adverse reactions (≥20%) for sotorasib 960 mg/panitumumab were rash, dry skin, diarrhea, stomatitis, fatigue, and musculoskeletal pain. The most common Grade 3-4 laboratory abnormalities in ≥ 2 patients were decreased magnesium, decreased potassium, decreased corrected calcium, and increased potassium.
• On Thursday, the FDA granted traditional approval to Calquence (acalabrutinib) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). FDA also granted traditional approval to acalabrutinib as a single agent for adults with previously treated MCL. Acalabrutinib received accelerated approval for this indication in 2017. Serious adverse reactions occurred in 69% of patients with acalabrutinib plus BR, and fatal adverse reactions occurred in 12%. Serious adverse reactions reported in ≥2% of patients were pneumonia, COVID-19, pyrexia, second primary malignancy, rash, febrile neutropenia, atrial fibrillation, sepsis, and anemia.

• On Wednesday, the FDA issued an order to revoke the authorization for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition that requested the agency to review whether the Delaney Clause applied.

  “The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs. The Delaney Clause is clear; the FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals. Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,” says Jim Jones, Deputy Commissioner for Human Foods.

• On Wednesday, the FDA requested comments about the FDA’s Digital Health Advisory Committee discussion during the meeting in November 2024 related to Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices. Please submit comments to docket FDA-2024-3924 on or before January 21, 2025. Note that late, untimely filed comments will not be considered.
• On Wednesday, the FDA’s Center for Veterinary Medicine released a request for information (RFI) soliciting comments from the public, particularly veterinarians, related to the use of cannabis-derived products (CDP) in animals. Information received through this RFI will enhance the FDA’s knowledge of potential safety signals associated with CDPs and improve the FDA’s understanding of veterinarians’ experiences related to the use of CDPs in their animal patients. The Federal Register Notice about the RFI contains instructions for submitting comments. The FDA will fully consider all comments, including comments submitted anonymously. The comment period for this RFI will be open for 90 days, ending on April 16, 2025.

• On Wednesday, the FDA’s Rare Disease Innovation Hub (the Hub) released its Strategic Agenda, which outlines the actions the Hub plans to undertake during its first year with extensive involvement from the rare disease community, while also addressing questions about the ultimate structure and programs of the Hub.  The Strategic Agenda reflects extensive input from and partnership with the larger rare disease community, and identifies the following goals for the Hub: 

  • Goal 1 – Further Advance Regulatory Science of Rare Disease Therapies
  • Goal 2 – Enhance and Strengthen Coordination and Alignment Between FDA’s Medical Product Centers, with Particular Focus on the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER)
  • Goal 3 – Create a Centralized Point of Contact for External Partners

  The Strategic Agenda is available on FDA’s website.

• On Tuesday the FDA published the Animal Welfare, Testing and Research of FDA-Regulated Products Consumer Update. Medical and veterinary products save lives every day. The FDA-regulated products undergo different types of testing to determine their safety and effectiveness. These tests may include animal testing, and they almost always include other types of tests. The FDA encourages and accepts scientifically valid alternatives to animal testing.
• On Tuesday, the FDA issued a Request for Information (RFI) on manufacturing processes and ingredients used to make certain dairy products which, for purposes of the RFI, we refer to as high-protein yogurt, Greek yogurt, or Greek-style yogurt (also collectively referred to as "high-protein yogurt" in this RFI). These dairy products are cultured with, at minimum, Lactobacillus delbrueckii, subspecies bulgaricus, and Streptococcus thermophilus. The FDA is taking this action, in part, because the existing yogurt standard of identity (SOI) may not align with certain manufacturing processes and ingredients used to concentrate protein to manufacture high-protein yogurt.
• On Monday, the FDA published a Spotlight on CDER Science featuring CDER's work with international regulators to develop a methodology, the Carcinogenic Potency Categorization Approach (CPCA), that uses the chemical structure of a nitrosamine impurity to recommend acceptable intake (AI) limits by assignment to 1 of 5 predicted potency categories reflecting carcinogenic risk. The application of the CPCA to determine recommended AI limits for nitrosamine impurities has expedited the regulatory review of drug safety assessments submitted by drug companies as an AI limit can be identified more efficiently and with greater transparency and predictability.