Summary of Recent FDA News and Updates

Today, the U.S. Food and Drug Administration (FDA) shared an overview of its recent activities and announcements:

• New Animal Drug Labeling Regulations Proposed: The FDA has proposed new regulations for the labeling of prescription and over-the-counter new animal drugs, including those for use in animal feeds. The goal is to provide drug sponsors with predictable requirements and ensure information is consistently presented for the safe and effective use of these drugs to veterinarians, animal owners, and producers. Public comments are invited until June 10, 2024.

• Accelerated Approval for Zanubrutinib: The FDA granted accelerated approval to zanubrutinib (Brukinsa) in combination with obinutuzumab for treating relapsed or refractory follicular lymphoma after at least two prior systemic therapies.

• Safety Alert for Ground Cinnamon: A safety alert was issued for certain ground cinnamon products sold across six retail chains due to elevated lead levels. Voluntary recalls are recommended.

• Nivolumab Approved for Urothelial Carcinoma: The FDA approved nivolumab (Opdivo) in combination with cisplatin and gemcitabine as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma.

• Inotuzumab Ozogamicin Approval for Pediatric ALL: Approval was granted to inotuzumab ozogamicin (Besponsa) for treating pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

• Spanish Versions of AR/VR Infographics Released: The FDA released Spanish versions of infographics on augmented and virtual reality technologies in healthcare, highlighting their potential to advance health equity.

• Consumer Update on Z-drugs for Insomnia: A reminder was issued about the benefits and risks associated with taking Z-drugs for insomnia, encouraging awareness among consumers.

• Funding for Antimicrobial Use Data Collection: Proposals for cooperative agreement funding are being accepted to support the collection of antimicrobial use data in animals, with up to $1.6 million available across fiscal years 2024 and 2025.

These updates reflect the FDA’s ongoing efforts to regulate medical and consumer products effectively, ensuring public health and safety.

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SUMMARY

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

• Today, the FDA announced proposed new regulations to provide animal drug sponsors with predictable requirements for the labeling of prescription and over-the-counter new animal drugs, as well as new animal drugs for use in animal feeds. The proposed content and format of labeling would also benefit veterinarians, animal owners, and animal producers by providing a more consistent presentation of information on the safe and effective use of these new animal drugs. The FDA is accepting public comments on the proposed rule for 90 days from the date of publication in the Federal Register. The public should submit either electronic or written comments on the proposed rule by June 10, 2024.
• On Thursday, the FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene USA, Inc.) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. View full prescribing information for Brukinsa.
• On Wednesday, the FDA issued a safety alert and recommended voluntary recalls for certain ground cinnamon products sold at six different retail chains nationwide due to the presence of elevated levels of lead. View the alert for ground cinnamon. 
• On Wednesday, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC). View full prescribing information for Opdivo.
• On Wednesday, the FDA approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). View full prescribing information for Besponsa.
• On Wednesday, the FDA released Spanish versions of two previously released infographics on augmented reality (AR) and virtual reality (VR). AR/VR are being used in health care settings as medical devices to treat patients with what is called medical extended reality (XR). Medical XR may help advance health equity by providing care outside of traditional health care settings, or when a specialist is not locally available.
• On Wednesday, the FDA reminded consumers in the Consumer Update: Taking Z-drugs for Insomnia? Know the Risks to be aware of the benefits and risks of taking insomnia medicines to help them sleep. 
• On Tuesday, the FDA announced that it is accepting proposals through May 13, 2024, for cooperative agreement funding to support the collection of antimicrobial use data from diverse animal sectors. The cooperative agreements provide up to three awards in fiscal year (FY) 2024 for a total of $600,000, and up to five awards in FY 2025 for a total of $1,000,000. The funding opportunities are the FDA’s latest step toward collecting information about the use of antimicrobials in animals.