- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Thursday, the FDA’s Learning and Education to ADvance and Empower Rare Disease Drug Developers initiative published two new videos titled “Understanding the Importance of Endpoints in Rare Disease Drug Development” and “Considerations for Collecting and Using Natural History Study Data that are Fit for Use in the Regulatory Setting” to our educational video series. The videos provide an overview of important considerations for selecting endpoints when designing clinical trials, and concepts to consider when determining how to leverage natural history study data to support regulatory decision making on a marketing application.
- On Wednesday, the FDA issued a Blue Box update to a Safety Alert on contaminated Korean oysters, adding additional recalled products.
- On Wednesday, the FDA celebrated 15 years since the passage of the Biologics Price Competition and Innovation Act (BPCIA). The BPCI Act created an abbreviated approval pathway to help provide patients with greater access to safe and effective biological products, and it established a framework to promote both innovation and competition. This year also marks the 10th anniversary since the approval of the first biosimilar in the United States. The FDA has approved 69 biosimilars since 2015. More information can be found at the CDER Conversation.
- On Wednesday, the FDA approved Exelixis, Inc.’s Cabometyx (cabozantinib)) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors. More information about Cabometyx can be found in the full prescribing information.
- On Wednesday, the FDA published the Pulse Oximeter Basics Consumer Update. Consumers are increasingly using pulse oximeters in-home when they are not feeling well or to monitor their general health. The FDA wants to help consumers breathe easy and know how these devices can be used safely and accurately.
- On Wednesday, the FDA provided an update from our ongoing postmarket evaluation of Essure by posting information on medical device reports received by the FDA related to Essure during the 2024 calendar year. Although Essure, a permanently implanted birth control device for women, has not been available for implantation since December 2019, the FDA remains committed to collecting and providing updates on the long-term safety information about Essure.
- On Tuesday, the FDA posted a web page celebrating the 100-year anniversary of the National Seafood Sanitation Program (NSSP). The NSSP is a partnership between certain states and federal agencies to prevent contaminated shellfish from entering the market. This program helps to ensure that bivalve molluscan shellfish (including oysters, clams, mussels, cockles, and scallops, other than adductor only) sold in the United States are safely produced and sold to consumers. The NSSP was established after a widespread deadly typhoid fever outbreak was traced to contaminated oysters in 1924.
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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.
