The U.S. Food and Drug Administration (FDA) has released an update summarizing recent developments within the agency.
As part of the FDA’s ongoing educational efforts, the Learning and Education to Advance and Empower Rare Disease Drug Developers initiative has introduced two videos. These are "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". The videos focus on selecting endpoints in clinical trials and using natural history study data for regulatory decisions.
Additionally, the FDA issued a safety alert update concerning contaminated Korean oysters, adding more recalled products to the list.
Marking a significant milestone, the FDA celebrated 15 years since the enactment of the Biologics Price Competition and Innovation Act (BPCIA). The Act facilitated an abbreviated approval process to enhance accessibility to biological products and promote innovation and competition. This year is also the 10th anniversary of the first biosimilar approval in the U.S., with the FDA approving 69 biosimilars since 2015.
The FDA has approved Cabometyx (cabozantinib) by Exelixis, Inc., for patients aged 12 and older with specific types of previously treated neuroendocrine tumors. Detailed prescribing information for Cabometyx is available.
An update on pulse oximeters providing basic consumer information was also released. This aims to guide consumers on the safe and accurate use of pulse oximeters for health monitoring at home.
Furthermore, the FDA has continued its postmarket evaluation of Essure, a discontinued birth control device for women. Despite its unavailability since 2019, the FDA is committed to reporting on Essure's long-term safety information.
The FDA also celebrated the 100-year anniversary of the National Seafood Sanitation Program (NSSP). The program, a federal and state partnership, aims to prevent contaminated shellfish from entering the market, ensuring their safe production and sale in the United States.
