FDA News Release
FDA Roundup: March 15, 2022
- For Immediate Release:
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- Today, the FDA is announcing the availability of two draft guidance documents: “Human Gene Therapy Products Incorporating Human Genome Editing,” and “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” The draft guidance, “Human Gene Therapy Products Incorporating Human Genome Editing,” is intended to provide recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. The draft guidance provides recommendations regarding information that should be provided in Investigational New Drug (IND) applications for GE products, including information on product design, product manufacturing, product testing, preclinical safety assessment, and clinical trial design. The draft guidance, “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products,” is intended to assist sponsors developing human gene therapy products in which the T cell specificity is genetically modified to enable recognition of a desired target antigen for therapeutic purposes. The guidance provides CAR T cell-specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design. While this guidance specifically focuses on CAR T cell products, much of the information and recommendations provided will also be applicable to other genetically modified lymphocyte products, such as CAR Natural Killer (NK) cells or T cell receptor (TCR)‑modified T cells.
- On March 14, the FDA and the Duke-Margolis Center for Health Policy announced a virtual public workshop on April 4-5 titled, Identifying Key Competencies for Opioid Prescriber Education. The workshop will build on discussions from the October 2021 Margolis-FDA convening on REMS opioid prescriber education. Including federal agencies, provider associations, licensing and accrediting organizations, education experts, and other key stakeholders aiming to alleviate the opioid and substance use crisis through improved education for opioid prescribers and other healthcare providers.
- On March 14, the FDA reopened the comment period for the draft Compliance Policy Guide (CPG) entitled “Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine” that was published on Dec. 27, 2021 (86 FR 73295). This CPG draft, when finalized, will assist the FDA in addressing adulteration associated with decomposition and histamine identified during surveillance sampling and testing. The original comment period closed on Feb. 25, 2022; the new comment period will close on April 13, 2022. Stakeholders will now have an additional 30 days to comment.
- On March 14, the FDA updated its frequently asked questions about the Philips Respironics CPAP, BiPAP, and ventilator recall on FDA.gov to include information about Philips Respironics’ prioritization strategy for replacement devices. After discussions with health care providers, experts in sleep medicine, and patient groups, the FDA shared with Philips Respironics the concerns of health care professionals and people who use these recalled devices, that for some patients, stopping use of the recalled device without an adequate alternative may involve significant risks to individual and public health. A first-come, first-served replacement strategy may not address these risks, or the risks from continued use of the recalled devices that such patients may face. For people with a recalled device: Philips Respironics’ online patient portal now allows them to provide additional information to be considered for prioritized replacement and to check the status of their replacement device. You may visit the online patient portal and update your information even if you did not receive an email notification from Philips Respironics.
- On March 14, the FDA provided an update from our ongoing post market evaluation of Essure by posting information on Medical Device Reports (MDRs) received by the FDA and Variance Adverse Event Reports related to Essure in 2021. The FDA remains committed to collecting and providing updates on Essure long-term safety information. Although Essure, a permanently implanted birth control device for women, has not been available for implantation since December 2019, the FDA continues to monitor the product’s safety through post market surveillance study data and other activities.
- On March 14, the FDA warned consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical for procedures intended to improve the appearance of the skin through:
- dermal resurfacing (a procedure on the skin to treat wrinkles) or
- skin contraction (a procedure under the skin that can be performed either alone or in combination with liposuction to achieve skin effects, such as “tightening”).
The use of this device has not been approved or cleared by FDA for use in any procedure intended to improve the appearance of the skin. The FDA has received reports describing serious and potentially life-threatening adverse events with use of this device for certain aesthetic procedures.
- On March 11, the FDA updated its Public Health Advisory and consumer update for Cronobacter Infections and powdered infant formula. This update includes a full list of recalled Abbott Nutrition brands, additional information for parents and caregivers of infants receiving medical specialty infant formula and individuals using certain medical foods.
- On March 10, as part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Soda Pharm for selling unapproved products with fraudulent COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
- Today, the FDA COVID-19 testing updates:
- As of today, 422 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests and 47 antigen tests. There are 70 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, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 876 revisions to EUA authorizations.
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.
- FDA Office of Media Affairs