|
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA is announcing the fiscal year (FY) 2025 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP). The user fee rates are authorized by the FDA Food Safety Modernization Act (FSMA) and allow the agency to assess and collect fees to cover the FDA’s cost of administering these programs.
- Today, the FDA issued a public health alert advising consumers to throw away and not buy nine additional ground cinnamon products due to the presence of elevated levels of lead. Please see our previous alerts on ground cinnamon products, March 6, 2024 alert, and July 25, 2024 alert, for a list of additional ground cinnamon products previously recommended for recall.
“We appreciate the continued work of our state partners to help us monitor lead in ground cinnamon in the market,” said Jim Jones, Deputy Commissioner for Human Foods. “Reducing dietary exposure to lead and other heavy metals among babies and young children is one of the top priorities of the human foods program and something we will continue to work on through the Closer to Zero initiative.”
- Today, the FDA officially opened the CDRH Center Director vacancy following the retirement of former CDRH Director Jeff Shuren. The post will remain open until August 27 as the agency conducts a national search for the next director to lead the Center. The Center Director is responsible for fulfilling CDRH’s mission to protect and promote the public health and to help ensure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. This position is being filled under a streamlined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act.
- On Friday, the FDA approved the Guardant Health, Inc. Shield, a test intended to screen for colorectal cancer (CRC) using blood collected in the Guardant Shield Blood Collection Kit. The test is used for CRC screening in individuals at average risk for the disease who are 45 years of age or older. Patients with positive test results should have a colonoscopy since the test is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous lesions. According to the American Cancer SocietyExternal Link Disclaimer, CRC is the second leading cause of cancer-related death among cancers that affect both men and women. This is the latest example of the FDA’s ongoing commitment to expanding colorectal cancer screening options for patients.
|
|
|
|
