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 In this section:

        Investigational New Drug (IND) Application

Pre-IND Consultation Program

                        
                Additional Resources Regarding Drug Development
          Division of Anti-Viral (DAV) Pre-IND Letter of Instruction
          Pre-IND Consultation Program Glossary Home
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          Development & Approval Process | Drugs
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          Investigational New Drug (IND) Application
          Pre-IND Consultation ProgramInvestigational New Drug (IND) Application Pre-IND Consultation Program
  	
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    Print**What is the Office of Infectious Diseases (OID) Pre-IND Consultation Program?**

In 1988, the Office of Antimicrobial Products (OAP), which is now the Office of Infectious Diseases (OID), established the Pre-Investigational New Drug Application (Pre-IND) Consultation Program.  This program is designed to facilitate and foster early communications between the divisions of OID and potential sponsors of new therapeutics (drugs, monoclonal antibodies, and therapeutic proteins) for the treatment of bacterial, fungal, and viral infections, opportunistic infections, emerging infections (including naturally emerging diseases and potential biothreat agents), and topical microbicides directed at prevention of HIV transmission. (21 CFR 312.82(a)).
Pre-IND advice may be requested for issues related to data needed to support the rationale for testing a drug in humans; the design of nonclinical pharmacology, toxicology, and drug activity studies, including design and potential uses of any proposed treatment studies in animal models; data requirements for an Investigational New Drug (IND) application; initial drug development plans, and regulatory requirements for demonstrating safety and efficacy.

We encourage all potential drug sponsors or investigators to examine the information available from this site and to initiate contact with us as early in the drug development process as possible, so that they will have the opportunity to consider our recommendations in planning preclinical and clinical development programs.**How Do I Obtain Further Information Regarding the Program?**
Please contact the appropriate Division for further information and specific contact information.

**The Division of Antivirals (DAV)** is responsible for:

HIV, AIDS and prevention of HIV transmission
	Viral hepatitis
	Herpesviruses
	Topical microbicides
	Emerging viral infections (including but not limited to respiratory viruses, zoonoses, and potential biologic threat agents)
	Other non-life-threatening and life-threatening viral infectionsFor more information, please visit the Office of Infectious Diseases Web page.**The Division of Anti-Infectives (DAI)** is responsible for:

Most systemic and topical antimicrobials
	Topical antiseptics
	Drug products for the adjunctive treatment of sepsis
	Drug products for treatment of Lyme diseaseFor more information please call 301-796-1400.***Note***: Pre-IND interactions should be considered as preliminary communications based on early development information, and will generally take the form of written comments that may be supplemented by teleconferences or meetings as needed and appropriate. Additions or modifications to these communications may arise as additional information becomes available, during follow-up pre-IND interactions or when an IND is established.
For the Pre-IND Consultation Program, please contact the appropriate division.

                                                                                  Content current as of:
      04/17/2020Pre-IND Consultation Program                
                          

                        Additional Resources Regarding Drug Development
          Division of Anti-Viral (DAV) Pre-IND Letter of Instruction
          Pre-IND Consultation Program Glossary
 
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