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: September 22, 2023Press Announcements FDA News Release
  FDA Roundup: September 22, 2023

  
  Share
    Post
    Linkedin

    Email
    PrintFor Immediate Release:
                  September 22, 2023
 

  
      
       

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

On Thursday, the FDA issued the revised, draft guidance *Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products*. This draft guidance outlines the recommendations to industry on formal meetings between the FDA and sponsors or applicants relating to the development and review of drug or biological drug products.  This draft guidance replaces the draft guidance *Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products* issued on December 29, 2017.
	On Wednesday, the FDA  provided an update on its work to advance its strategy to help prevent *Cronobacter sakazakii* illnesses associated with consumption of powdered infant formula. The update noted significant actions that have been taken to advance the goals of the strategy which can be found on the prevention strategy webpage.
	On Tuesday, the FDA announced that the Accreditation Scheme for Conformity Assessment (ASCA) program is converting from a pilot to a permanent program. This transition is authorized by the Medical Device User Fee Amendments of 2022 (MDUFA V). ASCA is a voluntary accreditation program that capitalizes on the increasingly prominent role of consensus standards in regulatory science. The ASCA program’s goals are to streamline conformity assessment in medical device submissions, enhance the FDA’s confidence in test methods and results, decrease the need for additional information related to conformance with a standard, and promote consistency, predictability and efficiency in medical device review.
	On Tuesday, the FDA issued the draft Center for Devices and Radiological Health International Harmonization Strategic Plan. This plan includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities, as applicable, and builds on the work CDRH is currently doing with international stakeholders. As the design, manufacture, distribution and use of medical devices have become increasingly complex and global, the need for harmonized approaches and reliance among regulatory authorities has become more vital. You can read the CDRH Statement here.
	The FDA Office of Women’s Health (OWH) works to protect, promote, and advance the health of women through research, education, and outreach. In collaboration with the Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP), OWH will host a free public workshop on October 11, 2023, Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research. The workshop will include presentations and session discussions by experts in the fields of clinical pharmacology, obstetrics and gynecology, endocrinology, and clinical care. Speakers will discuss the current understanding of the impact of menopause on the pharmacokinetics and pharmacodynamics (the movement of drugs through the body, and the body’s biological response to drugs, respectively), and exposure-response relationships of FDA-regulated drugs and biological products used by menopausal women for non-menopause-related indications. Researchers, educators, clinicians, and patients may benefit from attending this scientific workshop, which will be held virtually. To receive a link to attend, please register in advance.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:
      09/22/2023
               
               
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