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          OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023 - 06/08/2023FDA Meetings, Conferences and Workshops Town Hall
    Event Title
              OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023


                  June 8, 2023

  

    
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                Event MaterialsDate:
          
  


     
           

June 8, 2023   

 
 
        
                                      Time: 
                                      
11:30 AM
    - 1:00 PM
ET

 

  The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual town hall on Thursday, June 8, 2023. The event focused on cell therapy chemistry, manufacturing, and controls (CMC), including tissue-engineered medical products regulated by OTP.

View the June 2023 recording for the OTP Town Hall on Cell Therapy CMC.

Focus for This Town Hall: What Are Chemistry, Manufacturing, and Controls for Cell Therapy and Tissue-Engineered Medical Products?

The FDA requires sponsors to provide CMC information as part of an investigational new drug application. The CMC information should describe product manufacturing and testing to ensure safety, identity, quality, purity, and strength (including potency) of the investigational product. Please see this FDA guidance document or view materials from the December 2022 cell therapy CMC town hall event for more information.

About the OTP Town Hall Series

OTP, formerly OTAT, launched its virtual town hall series to engage with product development stakeholders and discuss topics related to OTP-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 OTP and view recordings from our previous town hall events.

View previous OTP Town Halls

September 2022: Gene Therapy Chemistry, Manufacturing, and Controls
	December 2022: Cell Therapy Chemistry, Manufacturing, and Controls
	February 2023: Clinical Development of Gene Therapy Products for Rare Diseases
	April 2023: Gene Therapy Chemistry, Manufacturing, and Controls

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Event Materials

  Title
            File Type/SizeTranscript - OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – June 2023
              pdf               (413.64 KB)

                                                                                  Content current as of:
      08/09/2023
         
                   
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