FDA Roundup: October 27, 2023

FDA News Release

• For Immediate Release: October 27, 2023

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

• Today, the FDA Center for Tobacco Products (CTP) Director Brian King published a statement summarizing the center’s continued efforts to address the operational evaluation of CTP by an independent expert panel facilitated by the Reagan-Udall Foundation (RUF). A comprehensive list of status updates for each recommendation is also available at the updated Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP webpage.  
• On Thursday, the FDA cleared Alltest Fentanyl Urine Test Cassette, the first over the counter test for the preliminary detection of fentanyl in urine. The test works by placing three drops of fresh urine onto a cassette containing a fentanyl test strip. After 5 minutes the test result will appear as colored lines.

“Opioid abuse, misuse and addiction is one of the most profound public health crises facing the U.S. today. It is also a very personal issue for many people, impacting individual lives and families,” said Jeff Shuren, M.D., J.D., Director, FDA’s Center for Devices and Radiological Health. “This test is an example of the FDA’s continued commitment to authorize tools that can reduce deaths associated with overdoses. The agency expedited review of this test, making a decision on the submission in only 16 days from the date it was received.”

The test provides only preliminary results. A more specific alternative chemical method (confirmation testing) must be used in order to obtain a confirmed test result. The test includes a pre-addressed mailing box for shipping samples to the manufacturer’s laboratory for confirmation testing. The test may provide incorrect results if the urine sample is contaminated, for example by adding bleach. The test does not distinguish between drugs of abuse and certain medications. Certain foods or food supplements may give a false positive test result.

• On Thursday, the FDA published CDER From Our Perspective: “Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products” by Sarah Yim, M.D., director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars (OTBB). Dr. Yim speaks to recent recommendations in OTBB draft labeling guidance that reflect experience with labeling considerations for biosimilar and interchangeable biosimilar products (interchangeable biosimilars), noting that the draft guidance recommendations have been revised to specifically include interchangeable biosimilar products. Dr. Yim also explains new recommendations for the “Biosimilarity Statement” in the “prescribing information” of biosimilar and interchangeable biosimilar product labeling. 
• On Thursday, the FDA approved Agamree (Santhera Pharmaceuticals, Inc.) an oral corticosteroid for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. DMD is a rare disorder which causes progressive muscle weakness due to a lack of muscle protein called dystrophin. Males are more commonly affected by the disorder which can be fatal. The most common side effects are cushingoid features (Cushing’s syndrome), psychiatric disorders, vomiting, weight gain and vitamin D deficiency. View the full prescribing information for Agamree. The FDA granted this application orphan drug designation.
• On Wednesday, the FDA published the FDA Voices: “India’s Unique Opportunity and Important Responsibility as the Pharmacy to the World,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. The FDA Commissioner Robert M. Califf recently traveled to India, visiting the capital city of New Delhi and the pharmaceutical and technology hub Hyderabad. He reflects about that trip in the FDA Voices article.
• On Wednesday, the FDA issued a draft guidance on Remote Interactive Evaluations of Drug  Manufacturing and Bioresearch Monitoring Facilities, replacing the previously issued guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. The FDA often used voluntary remote interactive evaluations during the COVID-19 pandemic. After their successful use, the FDA is issuing the draft guidance to inform industry about the agency’s continued use of such remote evaluations, as appropriate. 
• On Tuesday, the FDA issued an Outbreak Advisory for an investigation of Salmonella Thompson infections linked to fresh diced onions from Gills Onions of Oxnard, California. In response to this investigation, Gills Onions voluntarily recalled diced yellow onions, diced onions & celery, diced mirepoix, and diced red onions with use-by dates in August 2023. Consumers should not eat, sell, or serve recalled onions and should check their freezers if they froze recalled products. Full descriptions of recalled products sold to retailers in AZ, CA, ID, MT, OR, and WA can be found in the recall announcement.
• On Tuesday, the FDA approved Tibsovo (ivosidenib, Servier Pharmaceuticals LLC) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. The FDA also approved the Abbott RealTime IDH1 Assay as a companion diagnostic device for the selection of relapsed or refractory MDS patients with an IDH1 mutation. The most common adverse reactions were similar to common adverse reactions observed with ivosidenib monotherapy for  Acute Myeloid Leukemia. These include GI toxicities (diarrhea, constipation, mucositis, and nausea), arthralgia, fatigue, cough, myalgia, and rash. Tibsovo may also cause QTc prolongation. View full prescribing information for Tibsovo. 
• On Tuesday, the FDA, Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles. The 5 guiding principles outline key characteristics of robust Predetermined Change Control Plans (PCCPs). PCCPs are one way to support the development of safe, effective, and high-quality devices enabled with AI/ML technologies.

This joint publication is a continuation of the FDA’s international collaborations on good machine learning practice guiding principles. Together, these collaborations build on efforts outlined in the FDA’s Artificial Intelligence and Machine Learning Action Plan, and highlight the FDA’s desire predictability and principles harmonizing regulatory considerations across jurisdictions. For more information, please read the CDRH Statement.