FDA Roundup: October 3, 2023

SILVER SPRING, Md., Oct. 3, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

  • Today, the FDA, in partnership with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), announced the public workshop "Defining 'Candy-Like' Nonprescription Drug Products." The workshop will bring together stakeholders from the FDA, academia and industry to discuss available research on this topic, aid in the development of approaches for outlining appropriate dosage forms and consider patient-focused outreach to better understand how candy-like characteristics are viewed by consumers. The workshop will be held on Monday, October 30 from 8:30 a.m. to 4 p.m. ET both on-site at the FDA's White Oak Campus (Silver Spring, MD) and virtually. All attendees must register.
  • On Monday, the FDA issued minor updates to the final guidance: Electronic Submissions Template for Medical Devices 510(k) Submissions. The updates are to support the use of the Electronic Submission Template and Resource (eSTAR) through the CDRH Portal. As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR. Use of eSTAR for all 510(k) submissions is part of the FDA's ongoing efforts to modernize the 510(k) Program, and implement MDUFA V and 745A(b) of the Federal Food, Drug, and Cosmetic Act.

    eSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review. With a standardized format, submitters can ensure their submissions are complete, and the FDA can conduct premarket reviews more efficiently to help promote timely access to safe, effective, and high-quality medical devices.
  • On Friday, the FDA approved Rivfloza (Novo Nordisk Inc.), indicated to lower urinary oxalate (a substance consumed in food and produced by the body) levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1), a rare genetic disorder that can cause damage to the kidneys and other organs. The most common adverse reactions were injection site reactions. View the full prescribing information for Rivfloza.
  • On Friday, the FDA approved Tofidence (tocilizumab-bavi), the first biosimilar product to Actemra (tocilizumab), to treat rheumatoid arthritis in adults, polyarticular juvenile arthritis in ages 2 and older, and systemic juvenile idiopathic arthritis in ages 2 and older. The most common side effects associated with tocilizumab products are upper respiratory tract infections, nasopharyngitis (common cold), headache, hypertension, increased ALT (elevated liver enzymes), and injection site reactions. Please see the full prescribing information for additional information on risks associated with Tofidence. The FDA granted this approval to Biogen MA Inc.
  • On Friday, the FDA granted marketing authorization to the Procise IFX and Procise ADL assays, two in vitro diagnostic tests intended to measure levels of infliximab and adalimumab, respectively, medications used to treat patients with Crohn's disease and ulcerative colitis. Commonly referred to as inflammatory bowel diseases (IBD), Crohn's disease and ulcerative colitis affect more than three million patients in the U.S., according to the CDC. Many of these patients experience moderate to severe symptoms that require lifelong therapy to induce remission and prevent relapse. These marketing authorizations are the latest examples of the FDA's ongoing commitment to advance access to safe and effective diagnostic testing intended to aid healthcare professionals in making more informed clinical management decisions for patients.

Additional Resources:

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

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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SOURCE U.S. Food and Drug Administration

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