FDA Roundup: June 27, 2023

FDA News Release

• For Immediate Release: June 27, 2023

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

• Today, the FDA published new frequently asked questions and additional tools to provide industry with more information about the FDA Food Safety Modernization Act (FSMA) Food Traceability Rule. The Food Traceability Rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. 
• Today, the FDA published the FDA Voices: “Facilitating Review of Real-World Data Studies: The Oncology QCARD Initiative,” by Donna R. Rivera, PharmD., M.S., Associate Director for Pharmacoepidemiology, Oncology Center of Excellence (OCE) and Paul G. Kluetz, M.D., Deputy Director, OCE. The cancer drug development community could benefit from an enhanced understanding of information needs that can facilitate the evaluation of initial Real-World Data (RWD) study proposals. To address this issue, the FDA's Oncology Center of Excellence established a collaboration with the Reagan-Udall Foundation to evaluate essential data elements that could provide a starting point for characterizing the data source(s) and study design of an early RWD study proposal. The Oncology Quality, Characterization, and Assessment of Real-World Data (QCARD) Initiative aims to facilitate effective communication between study sponsors and protocol reviewers by evaluating the potential minimum elements that sponsors can consider when assembling submissions for review of a proposed study and RWD source(s).
• Today, the FDA issued the draft guidance: Patient-Matched Guides to Orthopedic Implants. Patient-matched guides are intended to help implement a pre-surgical plan to position an orthopedic implant during surgery. This draft guidance, when finalized, is intended to provide recommendations:
  • For information that manufacturers should include within a regulatory submission for patient-matched guides to orthopedic implants; and 
  • That manufacturers should consider when developing their design process for these device types.
• Today, the FDA issued a final guidance for industry entitled, “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” The purpose of the guidance is to provide industry with recommendations for presenting quantitative efficacy and risk information in Direct-To-Consumer promotional labeling and advertisements to make the language and presentation more consumer-friendly.  
• On Monday, the FDA approved Rystiggo for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor or antimuscle-specific tyrosine kinase antibody positive. The most common adverse reactions in patients with gMG are headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.