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        Development & Approval Process (CBER)

Investigational New Drug Applications (INDs) for CBER-Regulated  Products Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          Investigational New Drug Applications (INDs) for CBER-Regulated  ProductsDevelopment & Approval Process (CBER) Investigational New Drug Applications (INDs) for CBER-Regulated  Products
  	
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An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Clinical studies are often conducted to collect safety and effectiveness information in support of marketing applications for biologic and drug products. Unless exempted, the sponsor for a clinical study must obtain authorization from FDA for conducting the study by submitting an IND Application. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics Product License Application.

Expanded access to a product in an investigational stage can be granted by FDA as a compassion measure. These INDs are used for patients with serious diseases outside of clinical trials when no comparable or satisfactory alternative therapy options are available and are requested by the treating licensed physicians who determine whether the benefit outweighs the probable risk.

Clinical studies must follow a set of laws and regulations, which are intended to protect the right, safety, and welfare of human subjects participating in human trials, ensure the quality, validity, and integrity of the clinical trial data, and promote the availability of new medical products to the public. These laws and regulations define the roles and responsibilities of entities, such as sponsors, clinical investigators, and institutional review boards. In addition, various guidance documents and standard operating proceduresare available to clarify policies and procedures for the IND process.



Coronavirus (COVID -19) Related information

Recommendations for Investigational COVID-19 Convalescent Plasma

Additional Resources

Submission of an Investigational New Drug Application (IND) to CBER
	Regulatory Submissions in Electronic Format for CBER-Regulated Products
	Investigational New Drug (IND) Application
	Expanded Access to Experimental Biologics
	Emergency Use of an Investigational Drug or Biologic
	Expedited Programs
	Regenerative Medicine Advanced Therapy Designation
	CBER Advanced Technologies Team (CATT)
	Clinical Investigator Information
	References for the Regulatory Process for the Office of Tissues and Advanced Therapies
	CBER Standard Operating Policies & Procedures (SOPPs)Guidance Documents

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
	Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
	Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
	Clinical Trial Guidance Documents
	Product Development Under the Animal RuleLaws and Regulations

Biologics Rules
	Blood Donor Screening
Sub-Topic Paragraphs
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                                                                                  Content current as of:
      10/14/2022
                  
                   
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