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  5. FDA Roundup: January 10, 2023
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FDA News Release

FDA Roundup: January 10, 2023

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 issued the final guidance for the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals. FSVP is a regulation under the foundational FDA Food Safety Modernization Act, that makes importers accountable for verifying that foreign suppliers are producing food in a manner that meets U.S. safety standards.
  • Today, the FDA published an article for FDA Voices: “FDA Approved Many New Drugs in 2022 That Will Improve the Lives of Patients and Consumers,” by Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research. In 2022, CDER approved 37 new drugs never before approved or marketed in the U.S., known as “novel” drugs. Also approved were drugs in new settings, such as for new uses and patient populations. The 2022 approvals target many different disease areas. For example, the agency approved treatments for a range of infectious diseases, including COVID-19, HIV, smallpox, influenza, and H. pylori infection (a bacterial infection in the stomach). Also approved were therapies for two severe and progressive neurological conditions, amyotrophic lateral sclerosis and spinal muscular atrophy. The article links to the “New Drug Therapy Approvals 2022” report.
  • Today, the FDA’s Center for Devices and Radiological Health (CDRH) issued a statement regarding two recently issued warning letters to a leading manufacturer of endoscopes, Olympus Medical Systems Corporation, and one of its subsidiaries, Aizu Olympus Co, Ltd. following facility inspections. These warning letters concern violations related to medical device reporting (MDR) requirements and quality system regulations for endoscopes and endoscope accessories, including surgical and gastrointestinal endoscopes and automated endoscope reprocessors. These endoscopes are subject to reprocessing, which involves both cleaning and high-level disinfection or sterilization so the devices can be reused. These warning letters are the most recent in the history of CDRH’s compliance actions against Olympus related to MDR and quality system requirements. CDRH remains committed to ensuring the safety of reprocessed medical devices for U.S. patients and we have continued to work with multiple medical device manufacturers on this effort. You can read the full statement here.
  • Today, the FDA announced that the sixth in the ongoing series of webinars exploring food safety culture will take place on Jan. 25, 2023, from 12:00 to 1:00 pm ET. The upcoming webinar Food Safety Culture Learning: It's more than checking the boxes, will focus on how food safety culture relates to training and education.  The webinar series Collaborating on Culture in the New Era of Smarter Food Safety is in partnership with Stop Foodborne Illness, a non-profit health organization. 
  • Today, the FDA and Health Canada (HC) announced a joint pilot to test the use of a single eSTAR to both agencies. Applications for the pilot are now being accepted. The eSTAR is an interactive form that guides applicants through the process of preparing FDA medical device submissions. The pilot will test the use of a single eSTAR submitted for the following medical device submissions: 
    • HC applications:
      • Class III and Class IV 
    • FDA submissions:
      • 510(k)
      • De Novo
      • Premarket Approval (PMA) 
  • In-Vitro Diagnostics, combination products, CBER-led devices, and FDA dual 510(k)/CLIA Waiver applications are not included within the scope of this pilot.
  • The feasibility of using eSTAR will be determined by the outcome of a pilot with nine participants using the non-In Vitro Diagnostic eSTAR, which follows the structure of the IMDRF Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC).  Additional details, including how to Request to Participate, are described on FDA’s webpage.
  • Today, the FDA’s “The Real Cost” Youth Cigarette Prevention Campaign announced two new ads and, for the first time, will focus on the negative mental health effects of cigarette smoking and withdrawal in an ad. One ad – “Auctioneer” –  highlights the fact that cigarette withdrawal can lead to anxiety, and the other ad – “Said Every Smoker Ever” –  highlights the fact that 3 out of 4 teens will smoke into adulthood.  
  • On Monday, the FDA announced that it sent letters of acknowledgement to all manufacturers of infant formula that previously received letters of enforcement discretion for specific infant formula products and have expressed interest in taking steps to remain on the U.S. market. The agency has updated its web page on enforcement discretion to manufacturers to indicate the 11 companies that have expressed interest in taking these steps. To increase the diversity of and support a stable supply of infant formula in the U.S., the FDA is providing a pathway for manufacturers of certain infant formula products to continue marketing their products while they work toward meeting all applicable FDA requirements.
  • On Monday, the FDA licensed (approved) Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age. Additional information is available on the agency’s web site.
  • COVID-19 testing updates: 
    • As of today, 442 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 297 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and one diagnostic breath test. There are 79 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
    • The FDA has authorized 43 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1197 revisions to EUA authorizations

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