Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Press Announcements

Press Announcements Home
          News & Events
          FDA Newsroom
          Press Announcements
          FDA Roundup: October 17, 2023Press Announcements FDA News Release
  FDA Roundup: October 17, 2023

  
  Share
    Post
    Linkedin

    Email
    PrintFor 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.Related Information
  
  Related Information
              FDA Newsroom

###
  Boilerplate
      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.
Inquiries
  
    
        
         Media:
                 
      
                            FDA Office of Media Affairs
           
           
                      888-INFO-FDA
    Consumer:
                        888-INFO-FDA

                                                                                  Content current as of:
      10/17/2023
               
               
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical Devices   

        Follow FDA
            Follow @US_FDAon X
                Follow FDAon Facebook
                Follow @FDAMediaon XMore Press Announcements
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop