FDA Roundup: January 30, 2024

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Jan 30, 2024, 17:12 ET

SILVER SPRING, Md., Jan. 30, 2024 /PRNewswire/ -- 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 the FDA Voices: "FDA Enhances Global Patient and Regulatory Collaborations in Oncology," by Vaibhav Kumar, Division of Oncology 3 and Rea Blakey, Associate Director, Oncology Center of Excellence, External Outreach and Engagement. World Cancer Day, Feb. 4, is an international day to raise awareness of cancer prevention, detection, and treatment, and to support collaborative efforts to reduce suffering and death due to cancer. In recognition of World Cancer Day 2024, the FDA and the European Medicines Agency will collaborate to spotlight innovative cancer treatment advances for patients with CML, multiple myeloma, and melanoma, through a virtual public discussion on Feb. 1.
On Monday, the FDA revised the EUA for Paxlovid to continue to facilitate the transition from the U.S. government's distribution of Paxlovid labeled for use under the EUA to Pfizer's distribution of the commercial (NDA-labeled) Paxlovid. The FDA has issued a statement about this action.
On Friday, the FDA issued an expanded Safety Alert to warn consumers about nine additional products that contain toxic yellow oleander.
On Thursday, February 1, the FDA Oncology Center of Excellence in conjunction with the European Medicines Agency will host a Conversations on Cancer public panel discussion in recognition of World Cancer Day. The discussion will focus on the introduction of certain innovative therapeutic classes in the past two decades that have revolutionized the care of patients with chronic myeloid leukemia, multiple myeloma, and melanoma. The discussion will provide an overview of regulatory programs that expedite access to patients, including FDA's Breakthrough Therapy designation and Accelerated Approval; and EMA's Prime and Conditional Approval. The virtual public panel discussion will take place from 9:30 to 11 am ET (3:30 to 5 pm CET). Register here.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration