FDA Roundup: December 6, 2022

SILVER SPRING, Md., Dec. 6, 2022 /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 issued a final guidance, Homeopathic Drug Products, describing the agency’s approach to prioritizing enforcement and regulatory actions for homeopathic products marketed in the U.S. without the required FDA approval. The FDA has developed a risk-based approach under which the Agency intends to prioritize specific categories of homeopathic drug products that potentially pose a higher risk to public health, such as those intended for populations at greater risk for adverse reactions, including those with weakened immune systems, infants and children, the elderly, and pregnant women, as well as ophthalmic and injectable products, because the routes of administration for these products bypass some of the body’s natural defenses. The agency anticipates many homeopathic drug products will fall outside the categories of drug products it intends to prioritize for enforcement and regulatory action. There are no FDA-approved products labeled as homeopathic, and the agency cannot ensure these drugs meet standards for safety, effectiveness, and quality. Previously, the FDA warned the public about certain homeopathic products, including those containing a toxic substance and ones recalled due to contamination.
• Today, the FDA issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes information about new labeling and a required postmarket study for the AFX2 Endovascular AAA System (AFX2) to better inform patients and health care providers of the risk of Type III endoleaks. The FDA continues to recommend health care providers consider using available alternative treatment options for patients with abdominal aortic aneurysm (AAA) rather than the AFX2 device. In addition, the FDA continues to emphasize the importance for all patients who had their AAA treated with any AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) to have at least yearly, lifelong follow-up with a health care provider to monitor for Type III endoleaks.
• On Monday, registration opened for the FDA’s Rare Disease Day virtual event to be held on Monday, Feb. 27, 2023. This year’s theme is “Intersections with Rare Diseases – A patient focused event” which will explore a range of topics related to rare diseases. Participants will have the unique opportunity to:
  • Hear directly from the FDA on initiatives to advance medical product development for rare diseases
  • Engage with the FDA to provide your perspectives as a patient, caregiver or family member
  • Understand considerations and challenges associated with clinical trials in small populations
  • Hear from medical students on rare disease education for medical professionals
• On Monday, the FDA issued an update to our previous letter to health care providers to inform the health care community of the final post-approval study (PAS) results and updated labeling for the Impella RP System manufactured by Abiomed.
  • The final PAS results show that the survival rate for the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies is consistent with the premarket clinical studies survival rate and further confirms that the device is safe and effective when used for the currently approved indication.
  • The FDA approved updated labeling for the Impella RP System, based on the PAS results, with an update to the indications for use statement to better reflect the characteristics of the patients who may benefit the most from treatment with the device.
• COVID-19 testing updates:
  • As of today, 441 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 55 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 23 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
  • The FDA has authorized 39 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1169 revisions to EUA authorizations

Additional Resources:

• FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

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, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration