Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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[USA] FDA, Roundup (2022-08-26)
  • Registration Date 2022-08-31
  • Hit 376

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

  • Today, FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this time (a listing of additional resources is provided at the end of the checklist). Please see the updated Prescriber Patient Eligibility Screening Checklist for more information.
  • On Thursday, FDA approved a single dose vial presentation of COMIRNATY (COVID-19 Vaccine, mRNA). The single-dose vials have gray caps and labels with gray borders, and the vaccine must not be diluted before use. Each vial contains 1 dose of 0.3 mL. This presentation is approved for use in individuals 12 years of age and older. COMIRNATY is manufactured by Pfizer Inc. for BioNTech Manufacturing GmbH.
  • On Thursday, FDA posted additional FAQsExternal Link Disclaimer for stakeholders for the FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF). The new FAQs review general requirements for test methods used under the LAAF program; clarify that FDA does not maintain a comprehensive list of test methods performed by LAAF-accredited laboratories; and describe the specific test methods that are required in certain circumstances covered by the LAAF final rule.
  • On Wednesday, FDA issued the 2022 edition of the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) to detail the key elements of an effective retail food regulatory program for state, local, tribal and territorial regulatory agencies. The Retail Program Standards provide recommendations for designing and managing retail food regulatory programs and help regulatory jurisdictions (or other responsible organizations) facilitate more effective inspections, implement foodborne illness prevention strategies, and identify program areas in need of improvement.
  • On Tuesday, FDA issued a final guidance, “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention StudiesExternal Link Disclaimer.” The guidance provides information to assist applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product (MRTP) application, a premarket tobacco product application (PMTA), or a substantial equivalence (SE) report. The final guidance discusses a variety of scientific issues applicants may want to consider to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products. These studies in some circumstances can provide information to support product applications and this guidance provides recommendations on how to perform these studies.
  • COVID-19 testing updates:
    • As of today, 439 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1100 revisions to EUA authorizations.

Related Information

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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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