- 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 released Voices of the FDA: “Give Your Community a Boost: Fighting Misinformation Through Communication and Research,” by RADM Richardae Araojo, Pharm.D., MS, Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity. April is National Minority Health Month, and the US Department of Health and Human Services has chosen “Give Your Community a Boost” as this year’s theme. Over the past two years, the FDA has worked tirelessly with our U.S. government partners, medical product manufacturers, international partners, and other stakeholders to combat COVID-19. Although the pandemic continues, significant progress has been made in efforts to protect the health of Americans. The FDA has licensed and approved multiple vaccines, licensed multiple treatments, increased available testing options such as home testing, and provided countless educational resources in a variety of languages.
- On March 31, the FDA published the results of the inspection of Abbott Nutrition’s Sturgis, Michigan facility on the FDA Investigation of Cronobacter Infections: Powdered Infant Formula page. Five environmental subsamples taken from the Sturgis facility tested positive for Cronobacter sakazakii; four were detected by the FDA and one was detected by company-initiated testing. Environmental samples positive for Cronobacter sakazakii at the Sturgis facility were analyzed using whole genome sequencing, revealing five different strains of Cronobacter sakazakii. Product samples collected by the FDA from the facility were tested for Cronobacter by the FDA and tested negative. There are no additional FDA samples pending analysis at this time. On March 18, 2022, the FDA inspection at the Abbott Nutrition facility was completed and a Form 483 was issued which included four observations.
- On March 31, the FDA revised its guidelines, Emergency Use Authorization for Vaccines to Prevent COVID-19. The revised guidelines update recommendations for clinical data to support the efficacy of a COVID-19 vaccine that has been modified to target a particular SARS-CoV-2 variant of concern. The revised guidelines also provide the most up-to-date recommendations based on lessons learned during the COVID-19 public health emergency and sponsor submissions. The FDA also revised Section III (Criteria and Considerations for Issuing an EUA for a COVID-19 Vaccine) in the guidance to remove the expectation that sponsors should continue to collect placebo-controlled data after the issuance of an EUA. The agency made this review recognizing that the pandemic has evolved and that safe and effective COVID-19 vaccines have been licensed and approved. Thus, it may not be possible to continue collecting placebo-controlled data when an effective vaccine is licensed and available to study participants.
- On March 31, the FDA denied the request in two citizen petitions, from the Council for Responsible Nutrition and the Natural Products Association (NPA), asking the agency to determine that products containing N-acetyl-L-cysteine (NAC) are not excluded. of the definition of a dietary supplement under Section 201(ff)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). While the FDA’s response to the citizens’ petitions confirmed that NAC is excluded from the definition of a dietary supplement, the agency has yet to make a decision on the NPA citizens’ petition’s alternative claim that the agency is undertaking a regulation to authorize the use of NAC in dietary supplements.
- On March 30, the FDA released FDA Voices: “FDA’s Technology and Data Modernization in Action in 2022,” by Robert M. Califf, MD, MACC, Commissioner of Food and Drugs, and Vid Desai, Chief Information Officer. On the one-year anniversary of the FDA’s Data Modernization Action Plan, released in March 2021, and nearly three years after the launch of the Technology Modernization Action Plan, the agency provides an update on the progress of “modernization in action”. The anniversary report provides a detailed review of the progress being made to approach industry speed in streamlining workflows, reducing the cost of maintaining data and network security, and improving the speed of delivery of services.
- On March 30, the FDA announced that it was extending the public comment period for the Part 15 public hearing on “Scientific Residue Data and Information of Carcinogenic Concern for the New Animal Drug Carbadox.” The FDA is extending the comment period by 60 days, until June 10, 2022.
- On March 30, the FDA announced approval of new animal drug Zenalpha (medetomidine and vatinoxan hydrochloride injection) for use as a sedative and pain reliever to help keep dogs sedated and comfortable during exams or certain medical procedures.
- On March 30, the FDA updated the list of US health and human services regions where sotrovimab is not approved. This update is based on the Centers for Disease Control and Prevention (CDC) Nowcast Data estimates as of March 29 that the proportion of COVID-19 cases caused by the Omicron BA.2 variant is greater than 50% in these three regions.
- Sotrovimab is not authorized in the following states and territories:
- Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont (Region 1) (as of 03/25/2022)
- New Jersey, New York, Puerto Rico and the Virgin Islands (Region 2) (as of 03/25/2022)
- Illinois, Indiana, Michigan, Minnesota, Ohio and Wisconsin (Region 5) (as of 03/30/2022)
- Arizona, California, Hawaii, Nevada, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands and Republic of Palau (Region 9) (as of 03/30/2022)
- Alaska, Idaho, Oregon and Washington (Region 10) (as of 03/30/2022)
- Sotrovimab remains authorized in areas of the United States where the CDC Nowcast the point estimate of the proportion of the Omicron BA.2 variant remains below 50%.
- Sotrovimab is not authorized in the following states and territories:
- On March 29, the FDA approved the CartiHeal Ltd. Agili-C, a revolutionary device designed to treat defects or lesions that may occur in the cartilage covering the bones of the knee joint. The device is a small cylinder of material, implanted under the cartilage defect or lesion on the underlying bone where it gradually resorbs and is replaced by new cartilage. Agili-C is a porous, biocompatible and biodegradable material made from natural calcium carbonate derived from the purified, inorganic outer skeleton of coral.
- On March 29, the FDA cleared the BrainTemp Neonate System, an external neonatal brain temperature measurement system for healthcare professionals caring for neonates in intensive care units. , operating rooms and recovery rooms. Brain and core temperature of neonates are measured in circumstances where targeted temperature management may be indicated.
- Today, the FDA updated the Evusheld (tixagevimab co-packaged with cilgavimab) information sheet and Frequently Asked Questions with updated dosing information for patients who had already received the previously authorized starting dose. (150 mg of tixagevimab and 150 mg of cilgavimab). These patients should receive an additional dose of Evusheld as soon as possible, the dose being based on the following criteria:
- If the patient received their initial dose less than or equal to 3 months ago, the patient should receive a dose of 150 mg of tixagevimab and 150 mg of cilgavimab.
- If the patient received their initial dose more than 3 months ago, the patient should receive a dose of 300 mg of tixagevimab and 300 mg of cilgavimab.
- COVID-19 testing updates:
- To date, 425 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 293 molecular tests and sample collection devices, 84 antibody tests and other immune response tests and 48 antigen tests. There are 74 molecular clearances and 1 antibody clearance that can be used with home samples. There is one EUA for Molecular Prescription Home Testing, two EUAs for Antigen Prescription Home Testing, 15 EUA for Over-the-Counter (OTC) Antigen Home Testing and three for OTC Home Testing molecular.
- The FDA has cleared 28 antigen tests and nine molecular tests for serial screening programs. The FDA also authorized 910 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.