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FDA Roundup: May 20, 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:

  • On May 19, the FDA issued responses to two food additive petitions and a citizen petition requesting agency action on phthalates in food contact applications. The FDA amended its food additive regulations to no longer provide for most phthalates to be used in food contact applications. The agency also issued a request for information about available safety data and current use information of certain phthalates in food contact applications.
  • On May 19, the FDA published the FDA Voices: “FDA’s “All-in” Approach to Enterprise Transformation,” by Janet Woodcock, M.D., Principal Deputy Commissioner, and Meredith Chuk, M.D., Senior Medical Advisor, Director, Enterprise Transformation Operation. The article links to the agency’s new Enterprise Modernization Action Plan that lays out the pathway to more effective and efficient business processes, increased capabilities to better use the data that the agency reviews, and a more coordinated development of the IT systems designed to support these activities. These cross-agency efforts will also strengthen the alignment between agency-wide strategic objectives and investments.
  • On May 19, the FDA updated its safety communications and frequently asked questions about the Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls on FDA.gov to provide the latest information about medical device reports associated with the breakdown of the polyester-based polyurethane foam.
  • On May 17, the FDA published the refreshed Know Your Treatment Options for COVID-19 Consumer Update with the latest information on COVID therapies. The FDA has approved two drug treatments for COVID-19 and has authorized others for emergency use during this public health emergency.
  • On May 17, the FDA authorized marketing of BONESUPPORT AB Cerament G, the first device-drug combination product of its kind. The product is a bone void filler (bone graft substitute) with the antibiotic gentamicin added. It is intended as an adjunct to systemic antibiotic therapy and surgical debridement as part of the surgical treatment of osteomyelitis. Osteomyelitis occurs when an infection develops in a bone or spreads to a bone from another area of the body; risk factors for osteomyelitis include diabetes, surgery involving the bones, poor blood supply, recent injury, intravenous drug abuse or a weakened immune system.
  • The FDA’s Center for Devices and Radiological Health, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are pleased to invite you to the virtual 2022 Regulatory Education for Industry Annual Conference. The event will take place from June 6 through June 10, 2022. Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements. Registration and attendance are free. Visit the event page to register. To view the agenda, click here.
  • COVID-19 testing updates:
    • As of today, 433 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 83 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 78 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, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests. 
    • The FDA has authorized 27 antigen tests and 7 molecular tests for serial screening programs. The FDA has also authorized 978 revisions to EUA authorizations.
       

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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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