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        Development & Approval Process (CBER)

Biologics License Applications (BLA) Process (CBER) Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          Biologics License Applications (BLA) Process (CBER)Development & Approval Process (CBER) Biologics License Applications (BLA) Process (CBER)
  	
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    PrintThe Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:

Applicant information
	Product/Manufacturing information
	Pre-clinical studies
	Clinical studies
	LabelingKey Resources

Biologic Forms
	Vaccine Development – 101
	Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
	12/12/2007
	Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction
	12/26/2007
	Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov
	FDA Form 3674
	Federal Register Notice: New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule
	5/31/2002 (aka Animal Rule)
	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) deadlinesSub-Topic Paragraphs
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                                                                                  Content current as of:
      01/27/2021
                  
                   
Regulated Product(s)
		 BiologicsBiologics License Applications (BLA) Process (CBER)
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