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:

                News & Events

News & Events

                        


                        FDA Meetings, Conferences and Workshops
          OTP Events, Meetings, and Workshops
          Rumor Control
          Approvals of FDA-Regulated Products
          Congressional Testimony
          FDA Newsroom
          Interactive and Social Media
          Public Health Focus
          Speeches by FDA Officials Home
          News & Events
          OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls - 09/29/2022News & Events Town Hall
    Event Title
              OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls


                  September 29, 2022

  

    
  Share
    Post
    Linkedin

    Email
    PrintOn This Page
      Meeting Information
                Event MaterialsDate:
          
  


     
           

September 29, 2022   

 
 
        
                                      Time: 
                                      
11:30 AM
    - 12:30 PM
ET

 

  The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) hosted a virtual town hall to answer stakeholder questions related to gene therapy chemistry, manufacturing, and controls. This event was the first in a series to answer questions from stakeholders about a variety of topics on which OTAT has regulatory oversight.

View the recording for the OTAT Town Hall on Gene Therapy Chemistry, Manufacturing, and Controls.

Focus For The Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls

The FDA requires sponsors to provide information about chemistry, manufacturing, and controls (CMC) as part of investigational new drug, biologics license, and new drug applications. For gene therapies and other biologic products, the CMC information should describe the sponsor's commitment to perform manufacturing and testing to assure product safety, identity, quality, purity, and strength (including potency). Please see this FDA guidance documentfor more information about CMC data to support gene therapy product applications. In this town hall, subject matter experts from OTAT’s Division of Cell and Gene Therapy will answer questions related to CMC for gene therapy product development.

Submit a Question

This event has concluded. To see a list of future OTAT events, please visit the events calendar.

*Please note, the FDA is not able to comment on or answer questions regarding specific investigational products or drug applications during the town hall. Further, questions considered inappropriate or out of scope for the event will not be addressed.*

About the OTAT Town Hall Series

OTAT is launching the virtual town hall series to engage with product development stakeholders and discuss topics related to OTAT-regulated products. The town halls have a question-and-answer format with the goal of providing regulatory information to stakeholders to advance drug development. Learn more about OTAT and view our available resources.

Stay Connected

Sign up for the CBER listserv or follow us on social media to stay up to date on all FDA CBER news and events.





Event Materials

  Title
            File Type/SizeCBER OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls Transcript
              pdf               (370.92 KB)

                                                                                  Content current as of:
      11/17/2022
         
                   
Regulated Product(s)
		 BiologicsMore Meetings,
      Conferences, and
      Workshops
        
        News & Events

          
                        


                        FDA Meetings, Conferences and Workshops
          OTP Events, Meetings, and Workshops
          Rumor Control
          Approvals of FDA-Regulated Products
          Congressional Testimony
          FDA Newsroom
          Interactive and Social Media
          Public Health Focus
          Speeches by FDA Officials
 
 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