FDA Roundup: August 26, 2022

At present, the U.S. Meals and Drug Administration is offering an at-a-glance abstract of stories from across the company:  

• At present, FDA supplied extra steering to assist prescribers consider potential drug interactions when utilizing Paxlovid remedy for COVID-19. Prescribers ought to assessment every affected person’s full listing of medicines and use different sources to guage for potential drug interactions in sufferers who take drugs that aren’t included on the Reality Sheet or guidelines right now (an inventory of extra sources is supplied on the finish of the guidelines). Please see the up to date Prescriber Affected person Eligibility Screening Guidelines for extra info.
• On Thursday, FDA accepted a single dose vial presentation of COMIRNATY (COVID-19 Vaccine, mRNA). The one-dose vials have grey caps and labels with grey borders, and the vaccine should not be diluted earlier than use. Every vial comprises 1 dose of 0.3 mL. This presentation is accepted to be used in people 12 years of age and older. COMIRNATY is manufactured by Pfizer Inc. for BioNTech Manufacturing GmbH.
• On Thursday, FDA posted extra FAQs for stakeholders for the FDA Meals Security Modernization Act (FSMA) remaining rule on Laboratory Accreditation for Analyses of Meals (LAAF). The brand new FAQs assessment common necessities for check strategies used below the LAAF program; make clear that FDA doesn’t preserve a complete listing of check strategies carried out by LAAF-accredited laboratories; and describe the precise check strategies which are required in sure circumstances lined by the LAAF remaining rule.
• On Wednesday, FDA issued the 2022 version of the Voluntary Nationwide Retail Meals Regulatory Program Requirements (Retail Program Requirements) to element the important thing components of an efficient retail meals regulatory program for state, native, tribal and territorial regulatory companies. The Retail Program Requirements present suggestions for designing and managing retail meals regulatory applications and assist regulatory jurisdictions (or different accountable organizations) facilitate simpler inspections, implement foodborne sickness prevention methods, and determine program areas in want of enchancment.
• On Tuesday, FDA issued a remaining steering, “Tobacco Merchandise: Rules for Designing and Conducting Tobacco Product Notion and Intention Research.” The steering gives info to help candidates design and conduct tobacco product notion and intention (TPPI) research that could be submitted as a part of a modified threat tobacco product (MRTP) utility, a premarket tobacco product utility (PMTA), or a considerable equivalence (SE) report. The ultimate steering discusses quite a lot of scientific points candidates might wish to think about to evaluate, amongst different issues, people’ perceptions of tobacco merchandise, understanding of tobacco product info (e.g., labeling, modified threat info), and intentions to make use of tobacco merchandise. These research in some circumstances can present info to assist product functions and this steering gives suggestions on the right way to carry out these research. 
• COVID-19 testing updates:  
  • As of in the present day, 439 checks and pattern assortment gadgets are approved by the FDA below emergency use authorizations (EUAs). These embody 302 molecular checks and pattern assortment gadgets, 85 antibody and different immune response checks, 51 antigen checks, and 1 diagnostic breath check. There are 78 molecular authorizations and 1 antibody authorization that can be utilized with home-collected samples. There may be 1 EUA for a molecular prescription at-home check, 2 EUAs for antigen prescription at-home checks, 19 EUAs for antigen over-the-counter (OTC) at-home checks, and three for molecular OTC at-home checks.
  • The FDA has approved 31 antigen checks and eight molecular checks for serial screening applications. The FDA has additionally approved 1100 revisions to EUA authorizations.
     

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