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                Vaccines, Blood & Biologics

Vaccines, Blood & Biologics

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          Biologics Products & EstablishmentsVaccines, Blood & Biologics Biologics Products & Establishments
  
  	
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              notebook, pen, test tubes, and a beakerThis page contains a listing of biological product approvals and clearances with supporting documents; product/manufacturer lists; reports; related resources; and other product approval information.

Product Approvals & Clearances with Supporting Documents
	Cleared 510(k) Submissions with Supporting Documents
	Licensed Biological Products with Supporting Documents
	New Drug Applications with Supporting Documents
	Premarket Approvals with Supporting Documents   
Product / Manufacturer Lists
	Biological Approvals by Year
	510k Blood Establishment Computer Software
	Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
	Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases
	Immune Globulins
	FDA Online Label Repository
	Complete List of Licensed Products and Establishments
	Complete List of Substantially Equivalent 510(k) Device Applications
	Complete List of Currently Approved Premarket Approvals (PMAs)
	Complete List of Currently Approved NDA and ANDA Application Submissions
	Vaccines Licensed for Use in the United States
	Devices Regulated by the Center for Biologics Evaluation and Research
	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120   
Reports
	Fast Track Designation Request Performance
	Postmarketing Reports
	Biologics PREA Labeling Changes
	CBER Expanded Access Submission Receipt Reports   
Related Resources
	Compliance Actions (Biologics)
	National Drug Code Directory
	Search commercially distributed prescription drugs and insulin products
	Transfer of Therapeutic Products to the Center for Drug Evaluation and Research (CDER) - Archived   
Other Product Approval Information
	Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
	Drug Approvals and Databases
	CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting.
	Device Approvals, Denials and Clearances
	Center for Devices and Radiological Health
	Radiation-Emitting Products and Procedures
	Introduction to all radiation-emitting products and procedures.
	Products
	Information about Approved Animal Drug Products, Animal Food/Feed (including Pet Food), Imports & Exports, and the Generally Recognized as Safe (GRAS) Notification Program

                                                                                  Content current as of:
      03/07/2023
              
              
Regulated Product(s)
		 BiologicsVaccines, Blood & Biologics

          
                        Infectious Disease Tests


                        Fecal Microbiota Products
          Allergenics
          Blood & Blood Products
          Blood Donor Screening
          Cellular & Gene Therapy Products
          Development & Approval Process (CBER)
          Guidance, Compliance & Regulatory Information (Biologics)
          International Activities
          News & Events (Biologics)
          Resources for You (Biologics)
          Safety & Availability (Biologics)
          Science & Research (Biologics)
          Tissue & Tissue Products
          Vaccines
          Xenotransplantation
 
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