FDA Summary: March 15, 2022
- For immediate release:
Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from the agency:
- Today, the FDA announces the availability of two draft guidance documents: “Human Gene Therapy Products Incorporating Human Genome Editing” and “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell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 guidelines, “Human Gene Therapy Products Incorporating Human Genome Editing”, are intended to provide recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. The draft guidelines provide recommendations regarding the 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 guidelines, “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products,” aim to help sponsors develop human gene therapy products in which the specificity of T cells is genetically altered to allow recognition of a desired target antigen for therapeutic purposes. purposes. The guide provides recommendations specific to CAR T cells regarding chemistry, manufacturing and control (CMC), pharmacology and toxicology, and clinical study design. Although this guide focuses specifically on CAR T cell products, much of the information and recommendations provided will also be applicable to other genetically engineered lymphocyte products, such as CAR Natural Killer (NK) cells or T cells modified by the T cell receptor (TCR).
- 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 Training Opioid Prescribers. The workshop will be based on the discussions of October 2021 Margolis-FDA invitation on the training of REMS opioid prescribers. Including federal agencies, provider associations, licensing and accreditation bodies, education experts, and other key stakeholders working to alleviate the opioid and substance use crisis through better education of opioid prescribers and other healthcare providers.
- On March 14, the FDA reopened the comment period for the draft Compliance Policy Guide (CPG) titled “Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine” which was published on December 27, 2021 (86 FR 73295). This draft CPG, when finalized, will help the FDA address adulteration associated with decomposition and histamine identified during sampling and surveillance testing. The initial comment period ended on February 25, 2022; the new comment period will end on April 13, 2022. Stakeholders will now have an additional 30 days to comment.
- On March 14, the FDA updated its CPAP, BiPAP, and Philips Respironics ventilator recall FAQs on FDA.gov to include information about Philips Respironics’ prioritization strategy for replacement devices. After discussions with healthcare providers, sleep medicine experts and patient groups, the FDA has shared with Philips Respironics the concerns of healthcare professionals and individuals using these recalled devices that for some patients, discontinuing use of the recalled device without an alternative may involve significant individual and public health risks. A first-come, first-served replacement strategy may not take into account these risks, or the risks associated with continued use of the recalled devices that these patients may face. For people with a recalled device: Philips Respironics Online Patient Portal now allows them to provide additional information to consider for a priority replacement and check the status of their replacement device. You can visit the online patient portal and update your information even if you have not received an email notification from Philips Respironics.
- On March 14, the FDA provided an update to our ongoing post-marketing evaluation of Essure by posting information on medical device reports (MDRs) received by the FDA and adverse event reports related to Essure in 2021. The FDA remains committed to collecting and providing updates on Essure’s 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 safety of the product through data from surveillance studies. post-marketing and other activities.
- On March 14, the FDA warned consumers and healthcare providers against using the Renuvion/J-Plasma device by Apyx Medical for procedures intended to improve the appearance of skin by:
- dermal resurfacing (a procedure on the skin to treat wrinkles) or
- skin contraction (a procedure under the skin that can be performed 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 the FDA for use in any procedure intended to improve the appearance of the skin. The FDA has received reports describing serious and life-threatening adverse events related to the use of this device for certain cosmetic procedures.
- On March 11, the FDA updated its public health notice and consumer update regarding Cronobacter infections and powdered infant formula. This update includes a complete list of recalled Abbott Nutrition brands, additional information for parents and caregivers of infants receiving medical specialty infant formula, and people using certain medical foods.
- On March 10, as part of the FDA’s efforts to protect consumers, the agency sent a joint warning letter with the Federal Trade Commission to Soda Pharm for selling unapproved products with fraudulent claims of COVID- 19. Consumers concerned about COVID-19 should consult their healthcare provider.
- Today, the FDA’s COVID-19 testing updates:
- To date, 422 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 290 molecular tests and sample collection devices, 85 antibody tests and other immune response tests and 47 antigen tests. There are 70 molecular clearances and 1 antibody clearance that can be used with home samples. There is 1 EUA for molecular prescription home testing, 2 EUA for antigen prescription home testing, 14 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
- The FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA also authorized 876 revisions to EUA clearances.
The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.