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                Cellular & Gene Therapy Products

Cellular & Gene Therapy Products

                        Approved Cellular and Gene Therapy Products Home
          Vaccines, Blood & Biologics
          Cellular & Gene Therapy Products
          Consolidation of Wound Care Products Containing Live CellsCellular & Gene Therapy Products Consolidation of Wound Care Products Containing Live Cells
  
  	
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    PrintOn August 14, 2013, primary responsibility for regulating the following approved products  P950032, P960007, P000036, P010016, (all with product code MGR); H990013 (product code PBD); and H990002 (product code OCE), and all supplements included therein, was transferred from the Office of Device Evaluation, CDRH, to the Office of Tissues, and Advanced Therapies, CBER.  The jurisdictional assignment of these products to CBER is in accordance with section 503(g) of the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations (CFR) section 3.4.  This will consolidate primary responsibility for regulating wound care products containing live cells in CBER.

Submissions related to these approved products should be sent to CBER's document control room at the following address:

Center for Biologics Evaluation and Research
Office of Tissues, and Advanced Therapies
Document Control Center
10903 New Hampshire Avenue
WO71,G112
Silver Spring, MD. 20993-0002

Phone number: 240-402-8190

For specific assignment information within CBER, sponsors of transferred products and related submissions may contact Lori Tull at 240-402-8361 or via email at Lori.Tull@fda.hhs.gov



Resources For You

Cellular & Gene Therapy Products
	Consolidation of Wound Care Products Containing Live Cells; FR Notice

                                                                                  Content current as of:
      03/16/2018Cellular & Gene Therapy Products

          
                        Approved Cellular and Gene Therapy Products
 
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