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        Resources for You (Biologics)

Industry (Biologics)

                        
                CBER Advanced Technologies Program
          Manufacturers Assistance and Technical Training Branch (MATTB)


                Coronavirus (COVID-19) | CBER-Regulated Biologics Home
          Vaccines, Blood & Biologics
          Resources for You (Biologics)
          Industry (Biologics)Resources for You (Biologics) Industry (Biologics)
  	
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              vials and test tubesCBER’s Policies, Procedures, and Review Resources

This webpage provides important resources related to the regulatory framework of products regulated by CBER, including policies, procedures, and review resources.

CBER reviews applications for new products, new indications for already approved products, and product-related changes. This requires evaluating submitted scientific and clinical data to determine whether the product meets CBER's standards for approval. After a thorough assessment of the data, CBER makes a decision based on the risk-benefit for the intended population and the product's intended use. CBER's authority resides in the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act.

**Letter to Sponsors, Applicants and Regulated Entities on COVID-19**

**Beginning June 12, 2023, CDER and CBER will expand in-person FTF industry meetings (with a hybrid component), to include requests for Type B End-of-Phase 2 (EOP2), along with the previously announced Type A, BPD Type 1, and Type X meeting requests.** FTF meeting requests for other meeting types, if granted, will be held fully virtually (i.e., the in-person format will not be considered). Existing meeting requests received before June 12, 2023, or meetings already scheduled regardless of the scheduled meeting date, will not be converted to the in-person format, to permit fair implementation of the transition. For more information, please visit Update on In-Person Face-to-Face Formal Meetings with FDA. For general questions, please contact industry.biologics@fda.hhs.gov.

For detailed information on how to request a meeting with CBER and to find guidance on meeting request content, please visit Formal Meetings for CBER-Regulated Products | FDA.

Laws, Regulations, Guidances and Other Information

Biologics Guidances
	Biologics Procedures (SOPPs)
	Biologics Rules
	FDA Rules and Regulations
	Biosimilars
	Dockets Management
	Federal Food, Drug, and Cosmetic Act (FD&C Act)
	Federal Register (FR) Notices
	Generic Drug User Fee Amendments
	Memoranda to Blood Establishments
	Biosimilar User Fee Amendments
	Medical Device User Fee amendments (MDUFA)
	Prescription Drug User Fee Act (PDUFA)
	Food and Drug Administration Safety and Innovation Act (FDASIA)
	21st Century Cures Act
	The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and ExemptionsEstablishment Registration

Blood Establishment Registration and Product Listing
	Tissue Establishment RegistrationProduct Development

Frequently Asked Questions about Minimally Manipulated, Unrelated Cord Blood Products for Clinical Use
	Investigational New Drug Applications (INDs) for CBER-Regulated Products
	Clinical Investigator InformationProduct Application and Approval

Biologics License Applications (BLA) Process (CBER)
	Premarket Approval (PMA) for CBER-Regulated Products
	New Drug Application (NDA) Process (CBER)
	Premarket Notification 510(k) Process for CBER-Regulated Products
	Advertising & Labeling (Biologics)
	U.S. Food and Drug Administration Statement: The impact of February’s inclement weather on Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) deadlinesPostmarketing, Compliance and Enforcement

Biologics Post-Market Activities
	Biologic Product Security
	CBER-Regulated Products: Shortages and Discontinuations
	Compliance Programs (CBER)
	Impact of Severe Weather Conditions on Biological Products
	Exporting CBER-Regulated Products
	Lot Distribution Database (LDD)
	Product Surveillance (CBER)
	Recalls (Biologics)
	Report a Problem to the Center for Biologics Evaluation & Research
	Direct Recall Classification Program
	Safety & Availability (Biologics)
	Untitled Letters (CBER)
	Unique Device Identification - UDIMore Information

For IndustrySub-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:
      06/15/2023
                  
                   
Regulated Product(s)
		 BiologicsHealth Topic(s)
			  Infectious Disease
			    			       			    			       CoronavirusIndustry (Biologics)                
                          

                        CBER Advanced Technologies Program
          Manufacturers Assistance and Technical Training Branch (MATTB)


                        Coronavirus (COVID-19) | CBER-Regulated Biologics
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