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:

        Development & Approval Process (CBER)

New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated ProductsDevelopment & Approval Process (CBER) New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
  	
        Share
    Post
    Linkedin

    Email
    PrintNew Drug Application (NDA):

Historically, CBER has regulatory jurisdiction over some NDA products. Most NDAs are reviewed by the Center for Drug Evaluation and Research (CDER).

Examples of CBER NDAs include but are not limited to:

Red blood cell processing solution, such as for rejuvenation of red blood cells concentrate
	Products indicated for treatment of hypovolemia when plasma volume expansion is desired
	Anticoagulant solution used in the collection of un-anticoagulated donor blood samples
	Sterile bags containing anticoagulant intended for collection of umbilical cord blood
	Products intended for use as fluid replacement and plasma volume expansion in the adjunctive treatment of certain types of shock or impending shock, such as burns, surgery, hemorrhage and other trauma
	Solution designed to replace a proportion of the plasma used in storage of leuko-reduced apheresis platelets under standard blood banking conditionsFor more information, visit the CDER website: New Drug Application (NDA)

Abbreviated New Drug Application (ANDA):

There are only a few ANDAs currently regulated at CBER, e.g., ANDAs related to blood transfusion products. Most ANDAs are reviewed by CDER.

For more information, visit the CDER website: Abbreviated New Drug Application (ANDA)

Additional Resources:

Approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) with Supporting Documents for CBER-Regulated ProductsBiologics GuidancesBiologics Procedures (SOPPs)Master Files for CBER-Regulated ProductsGood Review Management Principles and Practices for New Drug Applications and Biologics License Applications
Sub-Topic Paragraphs
          Follow CBER
		Division of Communication and Consumer Affairs
			Office of Communication, Outreach and Development
			Center for Biologics Evaluation and Research
			Food and Drug Administration
			10903 New Hampshire Ave WO71-3103
			Silver Spring, MD 20993-0002
		
		ocod@fda.hhs.gov
		
		(800) 835-4709
			(240) 402-8010
		
		For Updates on Twitter, follow @fdacber
	Resources for You (Biologics)
			About the Center for Biologics Evaluation and Research (CBER)
			Report a Problem to the Center for Biologics Evaluation & Research
			Recalls (Biologics)
			CBER-Regulated Products: Shortages and Discontinuations
			Biologics Products & Establishments

                                                                                  Content current as of:
      04/26/2021
                  
                   
Regulated Product(s)
		 BiologicsNew Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
 
 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