WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has released a series of announcements covering a wide range of initiatives and regulatory updates, reflecting the agency’s ongoing commitment to public health, safety, and innovation.
Rare Disease Drug Development Educational Videos
On Thursday, March 27, the FDA’s Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative unveiled two new educational 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”, these videos aim to support developers by providing insights into clinical trial design and regulatory decision-making. The resources are part of a broader effort to assist in overcoming challenges associated with rare disease drug development.
Safety Alert on Contaminated Korean Oysters
On Wednesday, March 26, the FDA updated its Blue Box Safety Alert on Korean oysters linked to contamination. The revision includes additional recalled products to expand consumer awareness and prevent illness. Details of the specific products and distribution channels are available to the public to ensure proper response measures.
Celebrating 15 Years of the Biologics Price Competition and Innovation Act
The agency marked a significant milestone on March 26, celebrating 15 years since the passage of the Biologics Price Competition and Innovation Act (BPCIA). This legislation, enacted to boost affordability and accessibility of biological therapies, established an abbreviated approval pathway aimed at encouraging innovation and competition. The FDA also acknowledged the 10-year anniversary of the approval of the first biosimilar in the United States. To date, the FDA has approved 69 biosimilars, with trajectory growth anticipated to benefit more patients nationwide.
Expanded Approval for Cabometyx
On March 26, Exelixis, Inc.’s Cabometyx (cabozantinib) received FDA approval for expanded use in treating certain pancreatic and extra-pancreatic neuroendocrine tumors. The approval covers both adult and pediatric patients aged 12 years and older with previously treated, unresectable, locally advanced, or metastatic forms of these conditions. This move highlights the FDA’s dedication to supporting the advancement of targeted therapies for rare and complex diseases.
Consumer Update on Pulse Oximeter Safety
The FDA also issued a consumer-focused update on the proper use of pulse oximeters. These devices, increasingly popular for at-home health monitoring, play a critical role in assessing oxygen saturation levels. The agency emphasized the importance of understanding their limitations and provided best practices to ensure accurate readings and safe usage.
Postmarket Update on Essure Device
The FDA reaffirmed its commitment to monitoring the long-term safety of the Essure birth control device in its March 26 update. Essure, a permanently implanted device for women, has not been available for implantation since December 2019. However, the FDA continues to collect and publicly share postmarket medical device reports to ensure transparency about any potential safety concerns.
Milestone Anniversary for Seafood Safety Program
On Tuesday, March 25, the FDA celebrated 100 years of the National Seafood Sanitation Program (NSSP). Established in response to a deadly typhoid fever outbreak linked to contaminated oysters in 1924, the NSSP is a partnership between state and federal agencies that protects consumers by ensuring the safety of bivalve molluscan shellfish sold in the U.S. The program remains a vital element of the nation’s food safety infrastructure.
The FDA’s latest announcements reflect its multifaceted approach to addressing public health priorities, advancing scientific innovation, and preserving consumer trust.
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