FDA Roundup: October 17, 2023

FDA News Release

• For Immediate Release: October 17, 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’s The Center for Drug Evaluation and Research (CDER) announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. CDER is gathering information from internal and external stakeholders on the barriers and facilitators to incorporating innovative clinical trial approaches in drug development programs. Additionally, CDER, in partnership with Duke Margolis Center for Health Policy, is planning a public workshop on this topic on March 19 and 20, 2024. 
  Responses to this public docket will inform the public workshop and CDER’s future work related to clinical trial innovation. Comments to docket FDA-2023-N-4489 are now being accepted. For more information about submitting public comments, please refer to Regulations.gov.
• Today, the FDA published the “Catching Up with Califf”: “Advancing Nutrition, Healthy Food Options and Front-of-Package Labeling,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. Last month was the one-year anniversary of the White House Conference and National Strategy on Hunger, Nutrition and Health. The FDA continues to make great progress on our nutrition efforts, including our work to develop a front-of-package labeling system. This has the potential to be one of the most momentous changes to food labeling since the Nutrition Facts label. On November 16, the Reagan-Udall Foundation for the FDA will host a public meeting on front-of-package labeling to hear directly from stakeholders. 
• On Monday, the FDA announced the release of a new draft guidance for industry, Diabetic Foot Infections: Developing Drugs for Treatment. Diabetic foot infections (DFI) include cellulitis, ulcers, and bone and joint infections of the feet, below the ankle.  Foot infections in diabetic patients account for substantial morbidity and may result in lower limb amputations. To help industry in the development of antibacterial drugs for DFI, FDA is publishing a draft guidance which, when finalized, will articulate clinical trial design recommendations for these products.
• On Monday, the FDA approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). The most common adverse reactions reported in ≥ 20% of patients were nausea, fatigue, neutropenia, anemia, constipation, decreased appetite, white blood cell count decreased, musculoskeletal pain, rash, cough, vomiting, diarrhea and dyspnea. View full prescribing information for Keytruda.
• On Monday, the FDA announced a webinar regarding its proposed rule ”Medical Devices; Laboratory Developed Tests” (LDTs). The purpose of this webinar is to provide an overview of the proposed rule to amend the FDA’s regulations to make explicit that in vitro diagnostics products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory, and the proposed phase out policy under which the FDA intends to provide greater oversight of LDTs to help ensure their safety and effectiveness. The FDA will share information on the proposed amendment and phase out policy.
  • Webinar Date: Tuesday, October 31, 2023, from 1:00 PM – 2:00 PM ET
  • Location: webcast  
  • Registration: Not required
• The Q&A session will be based on questions that have been submitted to CDRHWebinars@fda.hhs.gov prior to the webinar. Questions will not be taken during the live webinar. All questions are due by October 23, 2023, to be considered for the webinar.
• On Friday, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older. The most common adverse reactions (reported in ≥20% of patients) were fatigue, musculoskeletal pain, rash, diarrhea, and pruritis. View full prescribing information for Opdivo.