June 18, 2024 - FDA Roundup: June 18, 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 announced a request for input about patient safety associated with certain medical software functions excluded from the medical device definition. This input will help the FDA develop the 2024 report on the risks and benefits to health of non-device software functions. Please submit comments under docket number FDA-2018-N-1910 at www.regulations.gov by July 18, 2024.
• The FDA recently issued a warning letter to Dollar Tree Inc., as an additional step following the investigation of lead and chromium in apple cinnamon fruit puree pouches this past fall that was prompted by findings of elevated blood lead levels in children. The FDA issued the warning letter to Dollar Tree, Inc., because, at the time of the recall, the company failed to adequately remove recalled WanaBana apple cinnamon fruit puree pouches from its store shelves. The FDA has asked the company to respond within 15 days of receipt of the warning letter stating the specific steps it has taken to address any violations and prevent the recurrence of violations or providing its reasoning and supporting information as to why the company believes it is not in violation of the law.
• On Monday, FDA approved the vaccine, Capvaxive, for the following indications and use:
  • for the prevention of invasive disease caused by 22 different serotypes of Streptococcus pneumoniae covered by the vaccine for individuals 18 years of age and older.
  • for the prevention of pneumonia caused by 21 different serotypes of Streptococcus pneumoniae covered by the vaccine for individuals 18 years of age and older.
  Streptococcus pneumoniae, also known as pneumococcus, are bacteria that can infect the lungs causing pneumonia, but when they infect the blood (bacteremia) or the coverings of the brain or spinal cord (meningitis) it is called invasive pneumococcal disease. It can be a very serious disease. The vaccine is manufactured by Merck Sharp & Dohme LLC.
• On Monday, the FDA announced the first of a series of five public meetings to provide educational sessions for stakeholders who are interested in the new animal drug approval process. The annual educational conferences the FDA will host over the next four years are described in the “Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028.” The first educational conference will be held on July 17, 2024, from 9 a.m. to 5 p.m. ET. Attendees can join in-person or virtually.   
• On Monday, the FDA’s Center for Devices and Radiological Health published a new blog: The Promise of Artificial Intelligence for Improving Health Care. Artificial intelligence (AI) is rapidly changing the health care industry and holds transformative potential. Among the possibilities AI offers are significantly improving patient care and medical professional satisfaction, accelerating and advancing research in medical device development and drug discovery, and driving operational efficiency by enabling personalized treatment and streamlining health care processes. At the FDA, we know that the proper integration of AI across the health care ecosystem will be important to achieving its potential while reducing risks and challenges.
• On Monday, the American Society of Addiction Medicine issued the draft “Clinical Practice Guideline on Benzodiazepine Tapering,” which is now available for public comment. The development of this guideline was funded by an FDA-provided grant and in partnership with the American Academy of Family Physicians, the American Academy of Neurology, the American Academy of Physician Associates, the American Association of Medical Toxicology, the American Association of Nurse Practitioners, the American Association of Psychiatric Pharmacists, the American College of Obstetricians and Gynecologists, the American Geriatrics Society, and the American Psychiatric Association.
• On Monday, the FDA approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma. Adverse reactions associated with pembrolizumab and chemotherapy were generally similar to those previously reported for pembrolizumab or chemotherapy with the exception of a higher incidence of rash. See the prescribing information for complete adverse reactions. Full prescribing information for Keytruda will be posted on Drugs@FDA. 
• On Friday, the FDA issued a Proposed Administrative Order: Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use. The agency is issuing this FDA-initiated proposed administrative order (proposed order), to address a safety issue related to over-the-counter monograph drug products containing acetaminophen. This proposed order, if finalized, would require drug companies to add a warning to the labeling. Additional information can be found in the CDER Statement about this proposed order. 
• On Friday, the FDA published a summary of the patient listening sessions held in March 2024 on Attention-Deficit/Hyperactivity Disorder (ADHD). The goal of the sessions is to help FDA’s staff better understand patient perspectives about their diagnosis and the risks and benefits associated with stimulant and non-stimulant treatment for ADHD.
• On Friday, the FDA approved durvalumab (Imfinzi, AstraZeneca UK Limited) with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). The most common adverse reactions (>25%) with durvalumab in combination with carboplatin and paclitaxel were peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, diarrhea, vomiting, and cough. Full prescribing information for Imfinzi will be posted on Drugs@ FDA..
• On Friday, the FDA approved blinatumomab (Blincyto, Amgen Inc.) for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy. In Study E1910, the most common adverse reactions (≥20%) in the blinatumomab arm were neutropenia, thrombocytopenia, anemia, leukopenia, headache, infection, nausea, lymphopenia, diarrhea, musculoskeletal pain, and tremor. In Study 20120215, the most common adverse reactions (≥20%) in the blinatumomab arm were pyrexia, nausea, headache, rash, hypogammaglobulinemia, and anemia. Full prescribing information for Blincyto will be posted on Drugs@FDA.

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